Pressure-garment therapy for preventing hypertrophic scarring after burn injury.

BACKGROUND: Burn damage to skin often results in scarring; however in some individuals the failure of normal wound-healing processes results in excessive scar tissue formation, termed 'hypertrophic scarring'. The most commonly used method for the prevention and treatment of hypertrophic scarring is pressure-garment therapy (PGT). PGT is considered standard care globally; however, there is continued uncertainty around its effectiveness. OBJECTIVES: To evaluate the benefits and harms of pressure-garment therapy for the prevention of hypertrophic scarring after burn injury. SEARCH METHODS: We used standard, extensive Cochrane search methods. We searched CENTRAL, MEDLINE, Embase, two other databases, and two trials registers on 8 June 2023 with reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing PGT (alone or in combination with other scar-management therapies) with scar management therapies not including PGT, or comparing different PGT pressures or different types of PGT. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected trials for inclusion using predetermined inclusion criteria, extracted data, and assessed risk of bias using the Cochrane RoB 1 tool. We assessed the certainty of evidence using GRADE. MAIN RESULTS: We included 15 studies in this review (1179 participants), 14 of which (1057 participants) presented useable data. The sample size of included studies ranged from 17 to 159 participants. Most studies included both adults and children. Eight studies compared a pressure garment (with or without another scar management therapy) with scar management therapy alone, five studies compared the same pressure garment at a higher pressure versus a lower pressure, and two studies compared two different types of pressure garments. Studies used a variety of pressure garments (e.g. in-house manufactured or a commercial brand). Types of scar management therapies included were lanolin massage, topical silicone gel, silicone sheet/dressing, and heparin sodium ointment. Meta-analysis was not possible as there was significant clinical and methodological heterogeneity between studies. Main outcome measures were scar improvement assessed using the Vancouver Scar Scale (VSS) or the Patient and Observer Scar Assessment Scale (POSAS) (or both), pain, pruritus, quality of life, adverse events, and adherence to therapy. Studies additionally reported a further 14 outcomes, mostly individual scar parameters, some of which contributed to global scores on the VSS or POSAS. The amount of evidence for each individual outcome was limited. Most studies had a short follow-up, which may have affected results as the full effect of any therapy on scar healing may not be seen until around 18 months. PGT versus no treatment/lanolin We included five studies (378 participants). The evidence is very uncertain on whether PGT improves scars as assessed by the VSS compared with no treatment/lanolin. The evidence is also very uncertain for pain, pruritus, adverse events, and adherence. No study used the POSAS or assessed quality of life. One additional study (122 participants) did not report useable data. PGT versus silicone We included three studies (359 participants). The evidence is very uncertain on the effect of PGT compared with silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, adherence, and other scar parameters. It is possible that silicone may result in fewer adverse events or better adherence compared with PGT but this was also based on very low-certainty evidence. PGT plus silicone versus no treatment/lanolin We included two studies (200 participants). The evidence is very uncertain on whether PGT plus silicone improves scars as assessed by the VSS compared with no treatment/lanolin. The evidence is also very uncertain for pain, pruritus, and adverse events. No study used the POSAS or assessed quality of life or adherence. PGT plus silicone versus silicone We included three studies (359 participants). The evidence is very uncertain on the effect of PGT plus silicone compared with silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, and adherence. PGT plus scar management therapy including silicone versus scar management therapy including silicone We included one study (88 participants). The evidence is very uncertain on the effect of PGT plus scar management therapy including silicone versus scar management therapy including silicone, as assessed by the VSS and POSAS. The evidence is also very uncertain for pain, pruritus, quality of life, adverse events, and adherence. High-pressure versus low-pressure garments We included five studies (262 participants). The evidence is very uncertain on the effect of high pressure versus low pressure PGT on adverse events and adherence. No study used the VSS or the POSAS or assessed pain, pruritus, or quality of life. Different types of PGT (Caroskin Tricot + an adhesive silicone gel sheet versus Gecko Nanoplast (silicone gel bandage)) We included one study (60 participants). The evidence is very uncertain on the effect of Caroskin Tricot versus Gecko Nanoplast on the POSAS, pain, pruritus, and adverse events. The study did not use the VSS or assess quality of life or adherence. Different types of pressure garments (Jobst versus Tubigrip) We included one study (110 participants). The evidence is very uncertain on the adherence to either Jobst or Tubigrip. This study did not report any other outcomes. AUTHORS' CONCLUSIONS: There is insufficient evidence to recommend using either PGT or an alternative for preventing hypertrophic scarring after burn injury. PGT is already commonly used in practice and it is possible that continuing to do so may provide some benefit to some people. However, until more evidence becomes available, it may be appropriate to allow patient preference to guide therapy.

A systematic review of the management of postoperative scars with silicone gel-based products in randomized controlled trials.

Although postoperative scarring may be considered a cosmetic concern, it can greatly impact a patient's quality of life. This extends beyond psychosocial burden influenced by hypertrophic scars and keloids, as patients also experience discomfort and pain. This systematic review evaluates the efficacy of silicone gel (SG)-based products in preventing postoperative abnormal scar formation. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a PubMed search was performed to find randomized, controlled trials investigating the effect of SG-based products on postoperative wound healing. The search yielded 359 publications, but only 30 studies published between 1991-2022 were found to fit the inclusion criteria. Outcomes were extracted from the literature and subsequent quality and risk of bias assessments were performed. Most studies indicated improvement of at least one quality of the scar with the use of SG-based products. The greatest potential variable increasing bias was an inadequate control group. Studies also suffered from small sample sizes, use of unvalidated scar assessment scales, lack of double-blinding, and short follow-up periods. Overall, SG-based products demonstrated potential in preventing abnormal scar formation during postoperative healing, but further studies are required to validate the results of current literature.

Micro-plasma radiofrequency and silicone gel dressings for treating early post-traumatic facial scars: A retrospective study.

BACKGROUND: Although different options are available for treating post-traumatic facial scars, they remain a therapeutic challenge. AIM: To evaluate the safety and effectiveness of combined therapy using micro-plasma radiofrequency (MPRF) technology and silicone gel (SG) dressings for treating post-traumatic facial scars. METHODS: This retrospective study was conducted at a single center. Patients with facial injuries in the outpatient and emergency units of the Department of Plastic Surgery at our hospital underwent debridement and cosmetic sutures performed by the same surgeon from October 2020 to October 2021. In the first arm, patients with facial injuries were treated with MPRF technology and SG, and in the second arm, they were treated with SG dressings alone. We observed the safety and effectiveness of these treatments in both arms. RESULTS: A total of 32 patients with facial injuries were treated with MPRF technology and SG dressings (combined treatment group), and 28 patients were treated with SG dressings alone (SG group). After 6 months of treatment, the Vancouver Scar Scale scores of the combined treatment and SG groups were 1.38 ± 0.71 and 4.39 ± 0.50, respectively, and the difference was statistically significant (P < 0.01). After 6 months of treatment, the effectiveness rate in the combined treatment group was 93.8%, which was significantly higher than that in the SG group (67.9%), and the difference between the two groups was statistically significant (P < 0.05). No obvious adverse reactions occurred in the two arms. CONCLUSION: Treating early post-traumatic facial scars with combined MPRF technology and SG is significantly better than treating them with SG alone; moreover, the combined therapy is safe and effective.

Comparison of LeniScar Silicone Stick (AnsCare) With Traditional Silicone Gel (Dermatix Ultra) in Wound Scar Prevention and Removal.

BACKGROUND: As we all know, the numbers of aesthetic surgery are increasing around the world. After the surgery, the scar would be a problematic issue for both the surgeons and the patients. Silicone has proven to be effective for keloids, hypertrophic scars, and prevention of scar formation in many literatures for a long time. In terms of scar prevention, silicone has been used in the form of silicone sheets in early times, which is later improved to be the form of silicone gel with the advantage of easier usage. Although silicone gel has improved greatly in the aspect of appearance and convenience of the silicone sheets, there are still some disadvantages of the gel form. Therefore, the LeniScar silicone stick (AnsCare) is invented. OBJECTIVE: This article aimed to compare the results of scar treatment and prevention of the AnsCare LeniScar Silicone Stick versus the traditional silicone gel (Dermatix Ultra). METHODS: This study was a prospective, nonblinded, randomized clinical study. There were a total of 68 patients from September 2018 to January 2020. Patients were divided into 2 groups with AnsCare (n = 43) and Dermatix (n = 25), who both were required to schedule regular outpatient clinic follow-up, and photographs were taken before use, 1, 2, and 3 months later after the usage for the record. The physician assessed the scar condition by the Vancouver Scar Scale (VSS). The scores of the VSS were further analyzed and compared. RESULTS: The overall P value of total score of VSS was 0.635, which indicates that there is no significant difference in using AnsCare LeniScar Silicone Stick versus Dermatix Ultra silicone gel in terms of scar prevention and treatment. Individual items of VSS such as pliability, height, vascularity, and pigmentation all show no significant statistical difference in the 2 treatment products, with P = 0.980, 0.778, 0.528, and 0.366, respectively. CONCLUSION: Traditional Dermatix Ultra silicone gel has been effective in the treatment of scar formation. AnsCare LeniScar Silicone Stick is statistically not different from the Dermatix Ultra silicone gel when comparing the treatment results of scar prevention. Furthermore, the AnsCare LeniScar Silicone Stick has the advantages of being time-saving with no need to wait for it to dry and application of precise amount to precise location, preventing waste or overuse.

Stem Cell-Enriched Hybrid Breast Reconstruction Reduces Risk for Capsular Contracture in a Hybrid Breast Model.

BACKGROUND: Hybrid breast reconstruction (HBR) combines silicone implants with fat grafting to improve implant coverage, treating local tissue deficiencies and leading to a more natural breast appearance. Recent data also indicated less capsular contracture after HBR. The authors developed a novel technique and animal model of cell-assisted (CA) HBR to illuminate its effects on capsular contracture. METHODS: Animals received silicone implants in a dorsal submuscular pocket. Although animals of the HBR group received fat grafting around the implant without stem cell enrichment, rats of the CA-HBR1 and the CA-HBR2 groups received stem cell-enriched fat grafting with 2 × 10 6 and 4 × 10 6 adipose-derived stem cells immediately after implant insertion. On day 60, animals underwent sonography and elastography imaging and were euthanized, and outcome analysis was performed by means of histology, immunohistochemistry, chemical collagen quantification, and gene expression analysis. RESULTS: With this novel technique, long-term survival of adipose-derived stem cells within the implant pocket was demonstrated after 60 days after implant insertion. CA-HBR led to significantly reduced thickness and collagen density of capsular contractures. In addition, CA-HBR resulted in reduced fibrotic responses with less occurrence of collagen type I and transforming growth factor-ß in capsule tissue. Moreover, the addition of stem cells suppressed fibrotic and inflammatory responses on a genetic level with significant underexpression of collagen type I and transforming growth factor-ß1. CONCLUSIONS: With this new technique and animal model, the authors observed a preventive effect on capsular contracture substantiating the basis of clinical outcomes of HBR. The authors propose that the addition of stem cells to HBR might booster its beneficial results. CLINICAL RELEVANCE STATEMENT: Stem cell-enriched fat grafting around silicone implants may reduce the risk for capsular contracture after silicone breast implantation. While fat grafting alone already shows beneficial effects, the addition of stem cells to the fat graft can potentiate this effect.

Silicone gel sheeting for treating keloid scars.

BACKGROUND: Keloid scarring is one of the most common types of pathological scarring. Keloid scars that fail to heal can affect a person's physical and psychological function by causing pain, pruritus, contractures, and cosmetic disfigurement. Silicone gel sheeting (SGS) is made from medical-grade silicone reinforced with a silicone membrane backing and is one of the most commonly used treatments for keloid scars. However, there is no up-to-date systematic review assessing the effectiveness of SGS for keloid scars. A clear and rigorous review of current evidence is required to guide clinicians, healthcare managers and people with keloid scarring. OBJECTIVES: To assess the effectiveness of silicone gel sheeting for the treatment of keloid scars compared with standard care or other therapies. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was December 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that recruited people with any keloid scars and assessed the effectiveness of SGS. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment, data extraction and GRADE assessment of the certainty of evidence. We resolved initial disagreements by discussion, or by consulting a third review author when necessary. MAIN RESULTS: Two studies met the inclusion criteria. Study sample sizes were 16 and 20 participants. The trials were clinically heterogeneous with differences in causes for scarring (e.g. surgery, infected wounds, and trauma), site (e.g. chest and back), and ages of scars. The duration of follow-up was three and four and a half months. The included studies reported three comparisons; SGS compared with no treatment, SGS compared with non-silicone gel sheeting (a dressing similar to SGS but which does not contain silicone), and SGS compared with intralesional injections of triamcinolone acetonide. One trial had a split-body design and one trial had an unclear design (resulting in a mix of paired and clustered data). The included studies reported limited outcome data for the primary review outcome of scar severity measured by health professionals and no data were reported for severity of scar measured by patients or adverse events. For secondary outcomes some data on pain were reported, but health-related quality of life and cost-effectiveness were not reported. Both trials had suboptimal outcome reporting, thus many domains in the risk of bias were assessed as unclear. All evidence was rated as being very low-certainty, mainly due to risk of bias, indirectness, and imprecision.  SGS compared with no treatment Two studies with 33 participants (76 scars) reported the severity of scar assessed by health professionals, and we are uncertain about the effect of SGS on scar severity compared with no treatment (very low-certainty evidence, downgraded once for risk of bias, once for inconsistency, once for indirectness, and once for imprecision). We are uncertain about the effect of SGS on pain compared with no treatment (21 participants with 40 scars; very low-certainty evidence, downgraded once for risk of bias, once for inconsistency, once for indirectness, and once for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness. SGS compared with non-SGS One study with 16 participants (25 scars) was included in this comparison. We are uncertain about the effect of SGS on scar severity assessed by health professionals compared with non-SGS (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). We are also uncertain about the effect of SGS on pain compared with non-SGS (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness. SGS compared with intralesional injections of triamcinolone acetonide One study with 17 participants (51 scars) reported scar severity assessed by health professionals, and we are uncertain about the effect of SGS on scar severity compared with intralesional injections of triamcinolone acetonide (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and once for imprecision). This study also reported pain assessed by health professionals among 5 participants (15 scars) and we are uncertain about the effect of SGS on pain compared with intralesional injections of triamcinolone acetonide (very low-certainty evidence, downgraded once for risk of bias, once for indirectness, and twice for imprecision). No data were reported for other outcomes including scar severity assessed by patients, adverse events, adherence to treatment, health-related quality of life and cost-effectiveness. AUTHORS' CONCLUSIONS: There is currently a lack of RCT evidence about the clinical effectiveness of SGS in the treatment of keloid scars. From the two studies identified, there is insufficient evidence to demonstrate whether the use of SGS compared with no treatment, non-SGS, or intralesional injections of triamcinolone acetonide makes any difference in the treatment of keloid scars. Evidence from the included studies is of very low certainty, mainly driven by the risk of bias, indirectness, and imprecision due to small sample size. Further well-designed studies that have good reporting methodologies and address important clinical, quality of life and economic outcomes are required to reduce uncertainty around decision-making in the use of SGS to treat keloid scars.

Cost-effectiveness of scar management post-burn: a trial-based economic evaluation of three intervention models.

Optimal burn scar management has the potential to markedly improve the lives of children, but can require substantial healthcare resources. The study aimed to examine the cost-effectiveness of three scar management interventions: pressure garment; topical silicone gel; combined pressure garment and topical silicone gel therapy, alongside a randomised controlled trial of these interventions. Participants were children (n = 153) referred for burn scar management following grafting, spontaneous healing after acute burn injury, or reconstructive surgery. Healthcare resource use was costed from a health service perspective (6-months post-burn time-horizon). The mean total scar management cost was lowest in the topical silicone gel group ($382.87 (95% CI $337.72, $443.29)) compared to the pressure garment ($1327.02 (95% CI $1081.46, $1659.95)) and combined intervention $1605.97 ($1077.65, $2694.23)) groups. There were no significant between-group differences in Quality Adjusted Life Year estimates. There was a 70% probability that topical silicone gel dominated pressure garment therapy (was cheaper and more effective), a 29% probability that pressure garment therapy dominated combined therapy, and a 63% probability that topical silicone gel dominated combined therapy. In conclusion, topical silicone gel was the cheaper intervention, and may be favoured in the absence of clear clinical effect favouring pressure garment therapy or a combination of these management approaches.Trial registration: ACTRN12616001100482 (prospectively registered).

Glucocorticosteroid and Silicone Gel During Patch Application Without Clinical Scar Improvement After Central Venous Catheter Removal: A Randomized Trial.

INTRODUCTION: We studied whether glucocorticosteroid during patch occlusion has a beneficial effect on scar outcome in children and adolescents treated for cancer. METHODS: A double-blinded placebo-controlled randomized clinical trial was performed. The main outcome was the Vancouver Scar Scale. Secondary outcomes were scar width and scar quality measured using the Patient and Observer Scar Assessment Scale. The patients were divided into an intervention groups and a control group. The intervention group was randomized into active and placebo group. The active treatment consisted of cream with glucocorticosteroid and fusidic acid. The placebo treatment consisted of cream with fusidic acid. Both groups received silicone gel patch after central venous catheter removal. The control group received no specific skin care. RESULTS: Assessment at 12 months showed that the intervention group had a significantly lower Vancouver Scar Scale and a smaller scar (0,1 cm) compared with the control group ( P =0.00, P =0.02) but no benefit of glucocorticosteroid. The Patient and Observer Scar Assessment Scale showed no significant difference between the intervention and control groups ( P =0.84, P =0.36). CONCLUSIONS: Silicone gel sheet alone or in combination with application of glucocorticosteroid during sheet occlusion does not clinically improve scar outcome after removal of central venous catheter in children treated for neoplastic diseases.

Prevention and management of hypertrophic scars after laparoscopic surgery using silicone gel sheets: a pilot study.

OBJECTIVE: To assess the effectiveness and safety of modified silicone gel sheets applied to hypertrophic scars and keloids following laparoscopic surgery. METHODS: Patients who had undergone laparoscopic surgery and who had either conventional or modified silicone gel sheets affixed to their surgical lesions for 6 months postoperatively (treatment groups), and control patients who had not received postsurgical treatment involving silicone gel sheets, were enrolled. The surgical wounds were assessed visually and using the Japan Scar Workshop (JSW) Scar Scale. Patients were interviewed before, 3 months after, and 6 months after sheet affixation. RESULTS: A total of 45 patients were included, comprising 15 patients per group. Both silicone gel-sheet groups had significantly lower JSW Scar Scale scores at 3 and 6 months after affixation compared with controls. The scores were not significantly different between the conventional and modified treatment groups and no adverse events were observed in the latter. CONCLUSIONS: Modified silicone gel sheets were more effective than controls and comparable to conventional gel sheets, and there were no adverse events related to laparoscopic surgical wounds in the improved silicone gel sheet group, demonstrating the safety and effectiveness of the modified silicone gel sheets.

The use of fluid silicone gels in the prevention and treatment of hypertrophic scars: a systematic review and meta-analysis.

BACKGROUND: Silicone products, either as a sheet or in fluid form, are universally considered as the first line therapy in the prevention and treatment of hypertrophic scars and keloids. However, the study results have been questioned by different authors and there has never been a large systematic synopsis published on the efficacy of fluid silicone gels. This systematic review aims to elucidate the available evidence of the results obtained by fluid silicone gels and present a complete and comprehensive overview of the available literature as well as a meta-analysis of the pooled data. METHODS: A systematic search for articles concerning the use of silicone gel in the treatment and prevention of scars was performed on 3 different databases (Pubmed, Embase and Cochrane library) according to the PRISMA statement. Only RCT's were included. Qualitative assessment was done by 2 separate reviewers using the Cochrane risk of bias (RoB 2) assessment tool. Revman 5.4.1 software was used for meta-analysis. RESULTS: The search yielded 507 articles. Two articles were identified through other sources. After deduplication and removal of ineligible records, 340 records were screened on title and abstract. Full text screening was done for 23 articles and ultimately 18 articles were included. A meta-analysis comparing fluid silicone gel to no treatment or placebo gels was conducted. CONCLUSION: Studies on the effects of liquid silicone gels on hypertrophic scars are numerous and this systematic review shows that the use of liquid silicone gels is associated with both a prophylactic and a curative effect on scars. However, a considerable amount of the available 'high evidence' trials are at a high risk for bias and it is uncertain whether or not the effects of silicone gels are comparable to silicone sheets and if the additional components present in many silicone gels are partially responsible for their scar improving capacity.

Synergistic Effects of Quercetin-Modified Silicone Gel Sheet in Scar Treatment.

Both silicone gel and quercetin are effective in scar treatment but have different action mechanisms. Quercetin is mainly applied in the gel form and can lead to poor adhesion of silicone gel sheet; therefore, they cannot be combined in clinical use. In this study, a silicone gel sheet that releases quercetin in a sustained manner for 48 hours was successfully developed. Four round scars (Ø: 1 cm) were made in the ears of New Zealand albino rabbits (n = 10). After scar healing, the rabbits were divided into four groups: blank control group with no treatment, silicone gel sheet group with dressing change every 2 days, quercetin group with dressing change three times daily, and combination treatment group with dressing change every 2 days. Scar assessment was performed 3 months later. Transepidermal water loss showed no difference between the combination treatment group and the silicone gel sheet group, but was lower than that in the quercetin group and the blank control group. Immunohistochemistry of CD 31 and proliferating cell nuclear antigen showed the following results: combination treatment group < silicone gel sheet group = quercetin group < blank control group. Polymerase chain reaction results showed that the expression of type-I and type-III collagen in the combination treatment group and the quercetin group was significantly lower than that in the other two groups. Thus, quercetin-modified silicone gel sheet combines the advantages of the two treatments and is more effective at inhibiting cell proliferation in scar tissue than either of the two treatments alone.

Silicone gel sheeting for treating hypertrophic scars.

BACKGROUND: Each year, in high-income countries alone, approximately 100 million people develop scars. Excessive scarring can cause pruritus, pain, contractures, and cosmetic disfigurement, and can dramatically affect people's quality of life, both physically and psychologically. Hypertrophic scars are visible and elevated scars that do not spread into surrounding tissues and that often regress spontaneously. Silicone gel sheeting (SGS) is made from medical-grade silicone reinforced with a silicone membrane backing and is one of the most commonly used treatments for hypertrophic scars. OBJECTIVES: To assess the effects of silicone gel sheeting for the treatment of hypertrophic scars in any care setting. SEARCH METHODS: In April 2021 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that enrolled people with any hypertrophic scars and assessed the use of SGS. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, 'Risk of bias' assessment, data extraction and GRADE assessment of the certainty of evidence. We resolved initial disagreements by discussion, or by consulting a third review author when necessary. MAIN RESULTS: Thirteen studies met the inclusion criteria. Study sample sizes ranged from 10 to 60 participants. The trials were clinically heterogeneous with differences in duration of follow-up, and scar site. We report 10 comparisons, SGS compared with no SGS treatment and SGS compared with the following treatments: pressure garments; silicone gel; topical onion extract; polyurethane; propylene glycol and hydroxyethyl cellulose sheeting; Kenalog injection; flashlamp-pumped pulsed-dye laser; intense pulsed light  and Gecko Nanoplast (a silicone gel bandage). Six trials had a split-site design and three trials had an unclear design (resulting in a mix of paired and clustered data). Included studies reported limited outcome data for the primary review outcomes of severity of scarring measured by health professionals and adverse events (limited data reported by some included studies, but further analyses of these data was not possible) and no data were reported for severity of scarring reported by patients. For secondary outcomes some pain data were reported, but health-related quality of life and cost effectiveness were not reported. Many trials had poorly-reported methodology, meaning the risk of bias was unclear. We rated all evidence as being either of low or very low certainty, often because of imprecision resulting from few participants, low event rates, or both, all in single studies. SGS compared with no SGS Seven studies with 177 participants compared SGS with no SGS for hypertrophic scars. Two studies with 31 participants (32 scars) reported severity of scarring assessed by health professionals, and it is uncertain whether there is a difference in severity of scarring between the two groups (mean difference (MD) -1.83, 95% confidence interval (CI) -3.77 to 0.12; very low-certainty evidence, downgraded once for risk of bias, and twice for serious imprecision). One study with 34 participants suggests SGS may result in a slight reduction in pain level compared with no SGS treatment (MD -1.26, 95% CI -2.26 to -0.26; low-certainty evidence, downgraded once for risk of bias and once for imprecision). SGS compared with pressure garments One study with 54 participants was included in this comparison. The study reported that SGS may reduce pain levels compared with pressure garments (MD -1.90, 95% CI -2.99 to -0.81;  low-certainty evidence, downgraded once for risk of bias and once for imprecision). SGS compared with silicone gel One study with 32 participants was included in this comparison. It is unclear if SGS impacts on severity of scarring assessed by health professionals compared with silicone gel (MD 0.40, 95% CI -0.88 to 1.68; very low-certainty evidence, downgraded once for risk of bias, twice for imprecision). SGS compared with topical onion extract One trial (32 participants) was included in this comparison. SGS may slightly reduce severity of scarring compared with topical onion extract (MD -1.30, 95% CI -2.58 to -0.02; low-certainty evidence, downgraded once for risk of bias, and once for imprecision). SGS compared with polyurethane One study with 60 participants was included in this comparison. It is unclear if SGS impacts on the severity of scarring assessed by health professionals compared with polyurethane (MD 0.50, 95% CI -2.96 to 3.96; very low-certainty evidence, downgraded once for risk of bias, and twice for imprecision). SGS compared with self-adhesive propylene glycol and hydroxyethyl cellulose sheeting One study with 38 participants was included in this comparison. It is uncertain if SGS reduces pain compared with self-adhesive propylene glycol and hydroxyethyl cellulose sheeting (MD -0.12, 95% CI -0.18 to -0.06). This is very low-certainty evidence, downgraded once for risk of bias, once for imprecision and once for indirectness. SGS compared with Gecko Nanoplast One study with 60 participants was included in this comparison. It is unclear if SGS impacts on pain compared with Gecko Nanoplast (MD 0.70, 95% CI  -0.28 to 1.68; very low-certainty evidence, downgraded once for risk of bias and twice for imprecision. There was a lack of reportable data from the other three comparisons of SGS with Kenalog injection, flashlamp-pumped pulsed-dye laser or intense pulsed light. AUTHORS' CONCLUSIONS: There is currently limited rigorous RCT evidence available about the clinical effectiveness of SGS in the treatment of hypertrophic scars. None of the included studies provided evidence on severity of scarring validated by participants, health-related quality of life, or cost effectiveness. Reporting was poor, to the extent that we are not confident that most trials are free from risk of bias. The limitations in current RCT evidence suggest that further trials are required to reduce uncertainty around decision-making in the use of SGS to treat hypertrophic scars.

Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children 12-months postburn: A parallel group randomised controlled trial.

OBJECTIVE: The longer-term effectiveness of silicone and pressure burn scar interventions was evaluated at 12-months postburn. DESIGN: Parallel group, randomised trial. SETTING: Hospital outpatient clinics, research centre. PARTICIPANTS: Children referred for burn scar management following grafted or spontaneously healed acute burn injuries or scar reconstruction surgery. INTERVENTIONS: Participants were randomised to: (1) topical silicone gel only, (2) pressure garment only, or (3) combined topical silicone gel and pressure garment. MAIN MEASURES: Primary outcomes were scar thickness (blinded ultrasound measurement) and itch intensity (caregiver proxy-report, numeric rating scale). RESULTS: Of 153 participants randomised who received the interventions (silicone n = 51, pressure garment n = 49, combined n = 53), 86 were followed-up at 12-months postburn (n = 34, n = 28, n = 24). No differences were identified for the primary outcomes using intention-to-treat analysis. Scar thickness mean difference (95% confidence interval) = 0.00 cm (-0.04, 0.05); -0.03 cm (-0.07, 0.02); 0.03 cm (-0.02, 0.08) and scar itch = 0.09 (-0.88, 1.06); -0.21 (-1.21, 0.79); 0.30 (-0.73, 1.32) for silicone vs pressure; silicone vs combined and combined vs pressure respectively. No serious adverse effects occurred. CONCLUSION: Similar to short-term results, the combined intervention offered no statistically or clinically significant benefit for improving the primary outcomes compared to each intervention alone. No differences in the primary outcomes were identified between the silicone and pressure alone groups.

Verapamil-containing silicone gel reduces scar hypertrophy.

A hypertrophic scar is a common dermal fibroproliferative lesion usually treated with topical silicone. Verapamil, a type of calcium channel blocker, is considered a candidate drug for the treatment of hypertrophic scars. Here, we report that the addition of verapamil to topical silicone gel enhances treatment outcomes of hypertrophic scars. Upon creation of hypertrophic scars with the rabbit ear model, varying concentrations of verapamil-added silicone gel (0.1, 1, and 10 mg/g) were applied daily for 28 days. After the animals were euthanised, microscopic measurement was performed for (a) scar elevation index (SEI), (b) fibroblast count, and (c) capillary count. On gross analysis, features of hypertrophic scars were significantly alleviated in the verapamil-added groups. On histologic examination, verapamil-added groups showed (a) reduced SEI (1.93 (1.79-2.67) for control vs 1.34 (1.21-1.51) for silicone only and 1.13 (1.01-1.65) for verapamil-added silicone), (b) fibroblast count 700.5 (599.5-838.5) for control, 613.25 (461-762.5) for silicone only, and 347.33 (182.5-527) for verapamil-added silicone), and (c) capillary formation (52 (35.5-96.5) for control, 46 (28-64.5) for silicone only, and 39.83(24-70) for verapamil-added silicone) (Kruskal-Wallis test, P < .05). On western blot, expression levels of collagen I protein was lower in the 1 mg/g and 10 mg/g verapamil-added silicone compared with control. Therefore, we suggest a therapeutic concentration of verapamil-added silicone gel of at least over 1 mg/g. Further study regarding maximally effective concentration and deeper insight into the mechanism of action should follow.

Effect of Soft Silicone Foam Dressings on Intraoperatively Acquired Pressure Injuries: A Randomized Study in Patients Undergoing Spinal Surgery.

The use of prophylactic dressings to help prevent intraoperatively acquired pressure injuries (IAPIs) merits further study. PURPOSE: To examine how the use of a soft silicone foam dressing affects the development of IAPIs in patients undergoing spinal surgery to obtain baseline data supporting evidence-based nursing care. METHODS: Using a self-controlled study design, 64 patients requiring thoracic or lumbar surgery on a Wilson frame at a hospital in Seoul, South Korea, were recruited between February 12 and September 1, 2018; 50 patients were eligible. Basic demographic, health, and surgical data were obtained. Before surgery, the left or right side chest and iliac crest areas were randomly assigned to be covered with a soft silicone foam dressing. The areas were assessed at 2 time points: immediately after and 30 minutes after surgery. If an IAPI was present at 30 minutes after surgery, all sites were reevaluated after 7 days. RESULTS: The majority of participants were male (26 participants, 52%). Average patient age was 62.54 (± 13.83) years, with a body mass index of 24.32 (± 4.23) kg/m2. Average length of surgery was 218.4 (± 137) minutes. Immediately after surgery, 26 IAPIs were observed and there was a significant difference between dressed and non-dressed chest areas for the number of IAPIs (4% vs. 28%; P = .002). After 30 minutes, the total number of IAPIs was 20 and the difference between IAPIs in the iliac crest area was significant between dressed and non-dressed areas (0% vs. 14%; P = .012). After 1 week, there were no chest or iliac crest IAPIs in the areas that had been covered by a dressing; however, 8 chest (61.5%) and 4 iliac crest (30.8%) area IAPIs remained when no dressing had been applied. The majority of IAPIs were stage 1 at all assessment times. After 1 week, 1 IAPI had evolved into a stage 3 injury. CONCLUSIONS: The results of this study show that many stage 1 IAPIs do resolve over time and that use of soft silicone foam dressings during spinal surgery can significantly reduce IAPI rates. Additional longitudinal studies are needed to help guide postoperative skin assessment intervals and increase the understanding about the evolution of stage 1 IAPIs.

Funnel usefulness in direct-to-implant breast reconstruction using periareolar incision with prepectoral implant placement and complete coverage with acellular dermal matrix.

BACKGROUND: The funnel has been used in esthetic breast surgery that requires a small incision. Recent advances in minimally invasive surgical techniques have led to more cases of nipple-sparing mastectomy (NSM) through periareolar incision. However, prepectoral implant placement and complete coverage with acellular dermal matrix (ADM) is almost impossible with the periareolar approach. Funnels can also be useful for direct-to-implant breast reconstruction. METHODS: NSM with periareolar incision and direct-to-implant breast reconstruction were performed with prepectoral implant placement between January 2017 and July 2019. The ADM full-wrapped anatomic textured implant was inserted using a funnel without additional incisions during surgery. RESULTS: A total of 21 patients were enrolled, including 2 who received bilateral breast reconstruction. All operations were successfully performed using funnels with minimal periareolar incisions. Anatomic textured implants (mean: 251.7 cc, range: 90-450 cc) wrapped in ADM can be effectively inserted in the prepectoral plane using a funnel. Two patients experienced delayed wound healing of the areola that was treated by conservative wound management. Patients also experienced less pain overall, and the cosmetic result was very good. Patient satisfaction scores were also very high. CONCLUSIONS: While the periareolar incision is esthetically pleasing, additional resection is often necessary. However, the use of funnels ensured that no additional incision was needed even in large implants. This subsequently led to better results in terms of pain and scarring. Prepectoral breast reconstruction involving complete implant coverage with ADM using a funnel through the periareolar approach represents a good alternative to the traditional dual plane subpectoral method. This method provides good patient satisfaction without adverse outcomes.

Remodelación autóloga mamaria. Importancia de la transferencia grasa y uso de los colgajos dermograsos locales en las grandes pérdidas ponderales / Autologous breast remodeling. Importance of fat transfer and use of local dermal-fat flaps in the massive weigth loss

INTRODUCCIÓN Y OBJETIVO: El aumento de la cirugía bariátrica como alternativa al tratamiento tanto del síndrome metabólico como de la obesidad y el sobrepeso, conlleva múltiples deformidades corporales, entre las que unas de las más complejas son las alteraciones mamarias. Su tratamiento quirúrgico depende de un diagnóstico y técnica adecuados, capaces de remodelar la estética mamaria. El objetivo de esta investigación es definir la importancia del injerto de grasa como procedimiento previo a la mamoplastia en pacientes que han sufrido grandes pérdidas ponderales. MATERIAL Y MÉTODO: Realizamos un estudio retrospectivo, lineal, en 124 pacientes sometidas a 158 procedimientos quirúrgicos consecutivos entre enero de 2009 y diciembre de 2019, con rango de edad entre 18 y 72 años. Evaluamos los procedimientos para la corrección de las diversas deformidades mamarias tales como, hipotrofia o atrofia mamaria, ptosis, asimetrías, posicionamiento lateralizado del complejo areola pezón, pérdida de la proyección del polo superior, flacidez cutánea asociada a lipodistrofia corporal persistente, cirugías previas de contorno corporal, así como la edad y el índice de masa corporal (IMC). RESULTADOS: El mayor porcentaje de procedimientos correspondió a la triple interposición de colgajos (28%, 44 procedimientos), seguida del injerto de grasa mamaria (27%, 42 procedimientos) y la triple interposición de colgajos con implante de silicona (19%, 30 procedimientos). Se realizó injerto graso mamario en un 40.50% de los procedimientos realizados, con una media de volumen graso infiltrado de 450.60 ml. CONCLUSIONES: Recomendamos la realización de injertos de grasa en todas las pacientes sometidas a cirugía de remodelación mamaria secundaria a pérdida masiva de peso con el fin de recomponer volumétricamente la mama y reconstruir estructuras cutáneas, parenquimatosas y musculares, siendo la transferencia de grasa mamaria la única forma de relleno definitiva del polo superior. Los colgajos locales representan no solo una forma de aumento volumétrico de la mama sino también una posibilidad de mejorar el contorno mamario y el segmento superior del cuerpo

BACKGRAUND AND OBJECTIVE: The increase in bariatric surgery as an alternative to the treatment of both the metabolic syndrome and obesity and overweight leads to multiple bodily deformities, among these one of the most complex are mammary alterations. The surgical treatment of these alterations depends on an adequate diagnosis and a suitable technique able to reshape the mammary aesthetics. The objective of this research is to define the importance of fat grafting as a procedure prior to breast-plasty in patients with post-weight loss. METHODS: A retrospective and linear study was performed in 124 patients, who underwent 158 consecutive procedures between January 2009 and December 2019, age range between 18 and 72 years. The evaluated procedures allowed correction of different breast deformities such as hypotrophy or breast atrophy, ptosis, asymmetries, lateral positioning of the nipple areola complex, loss of the upper pole projection, skin flaccidity associated with persistent body lipodystrophy, previous body contour surgeries, and patient's age and body mass index (BMI). RESULTS: A total of 158 procedures were performed which the highest percentage was of triple flap interposition (28%, 44 procedures), followed by breast fat grafting (27%, 42 procedures) and triple flap interposition with silicone implants (19%, 30 procedures). The fat graft to breast was performed in 40.50% of the total procedures performed, with a mean infiltrated fat volume corresponded to 450.60 ml. CONCLUSIONS: We recommend performing fat grafts in all patients undergoing breast remodeling procedures after massive weight loss in order to volumetrically recompose the breast and rebuild skin, parenchymal and muscular structures, with breast fat transfer being the only way definitive filling of the upper pole. In addition, local flaps represent not only a form of volumetric augmentation of the breast but also a possibility of improving the breast contour and upper body segment

Comparison of Silicone Sheets and Paper Tape for the Management of Postoperative Scars: A Randomized Comparative Study.

OBJECTIVE: To compare the effectiveness of silicone sheets and paper tape in the prevention of postoperative cesarean section scars. METHODS: Patients undergoing horizontal cesarean section were included in this randomized controlled trial. Surgical wounds were divided into two halves. Patients randomly applied silicone sheets or paper tape to each side of their wound as assigned for 3 months. Wounds were assessed at 1, 3, 6, and 12 months after surgery. Researchers used the objective Vancouver Scar Scale (VSS) to evaluate the scars and the subjective visual analog scale (VAS) to evaluate itch, pain, and scar appearance. RESULTS: No significant differences between the silicone sheet and paper tape groups were noted at postoperative follow-ups with respect to VSS scores. The silicone sheet group had significantly better VAS scores for scar appearance than the paper tape group at 6 (6.81 ± 1.47 vs 6.19 ± 1.62, P = .03) and 12 (6.88 ± 2.01 vs 6.2 ± 2.08, P = .04) months' follow-up, respectively. CONCLUSIONS: The silicone sheet group showed statistically significant differences in comparison with the paper tape group in terms of scar appearance as determined by the VAS. However, the differences were too small to be clinically meaningful.

Efficacy of topical silicone gel in scar management: A systematic review and meta-analysis of randomised controlled trials.

To assess the efficacy of topical silicone gel in the management of scars, we conducted this meta-analysis. The systematic search was performed on PubMed, Web of Science and Embase, and six randomised controlled trials with a total of 375 patients were involved. The outcome data of Vancouver Scar Scale were extracted from the studies and their effect sizes were calculated using Review Manager 5.3. As a result, topical silicone gel significantly reduced pigmentation, height, and pliability scores postoperatively compared with placebos or no treatment (Pigmentation: standard mean difference [SMD] = -0.55 [-0.83 to -0.26], P = .0002; Height: SMD = -0.73 [-1.02 to -0.44], P < .00001; Pliability: SMD = -0.49 [-0.95 to -0.03], P = .04). Topical silicone gel and silicone gel sheet were comparably effective (P > .05). The performance of topical silicone gel and other non-silicone topical treatment was also similar (P > .05). In summary, topical silicone gel was effective in post-operative scar prevention.

Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial.

BACKGROUND/AIM: To evaluate whether topical use of a film-forming silicone gel (StrataXRT®) could reduce radiation dermatitis compared to a moisturizing cream (X-derm®) in patients receiving whole breast radiotherapy. PATIENTS AND METHODS: A total of 56 patients with breast cancer were randomized to use StrataXRT or X-derm. The severity of radiation dermatitis was graded using physiological skin parameters, clinician-assessed visual rating scales and patient-reported symptoms. Changes in these parameters from baseline to 4 weeks post-radiotherapy were evaluated every two weeks. RESULTS: Two-way repeated-measures ANOVA revealed different patterns of changes in the erythema index (F=3.609, p=0.008) and melanin index (F=3.475, p=0.015). The post hoc analysis demonstrated a significantly lower erythema index and melanin index in the patients allocated to the StrataXRT group. CONCLUSION: The use of StrataXRT can reduce radiation dermatitis with respect to objectively measured physiological skin parameters. The results of the present study will support the feasibility of conducting a larger randomized controlled trial.