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.

Gazing Long into a Clinical and Social Abyss? Treating Hypertrophic Scarring and Keloids.

This commentary discusses the unmet clinical and social needs associated with hypertrophic scars and keloids. The authors critically appraise these issues within the context of contemporary clinical standards of care and social mores catalyzed by the COVID-19 pandemic.

Quantitative assessment of treatment efficacy in keloids using high-frequency ultrasound and shear wave elastography: a preliminary study.

The purpose of this study was to investigate the performance of high-frequency ultrasound (HFUS) and shear wave elastography (SWE) in the quantitative evaluation of therapeutic responses of keloids. 43 patients with 76 keloids were recruited into this study. In keloids and symmetrical sites, the skin thickness was measured using HFUS and skin stiffness expressed as elastic moduli (Young's modulus and shear wave velocity) was measured using SWE. The coefficient of variation values were calculated by using difference values of skin elastic moduli and skin thickness. A significant increase of both skin stiffness and thickness appeared in pre-treated keloids compared with post-treated keloids (P < 0.001) and normal controls (P < 0.001), respectively. Stiffness in post-treated keloids and normal skins was significantly different (P < 0.001), while the difference in thickness measurements showed no significance (P = 0.56, >0.05). The coefficient of variation of Young's modulus was the highest when compared between (i) pre-treated keloids and theirs site-matched areas; (ii) pre-treated and post-treated keloids. SWE, which showed greater ability in determining the extent of keloids recovery, may provide an ideal tool to assess the stiffness of keloids and theirs therapeutic response.

Assessment of the Combined Efficacy of Needling and the Use of Silicone Gel in the Treatment of C-Section and Other Surgical Hypertrophic Scars and Keloids.

OBJECTIVE: To evaluate the individual effectiveness of needling therapy using the Dermapen (Dermapen, Salt Lake City, Utah) and topical therapy with silicone gel (Kelo-cote, Sinclair Pharma, London, England), and their combined effectiveness for the treatment of linear surgical scars, hypertrophic scars, and keloids. MATERIALS AND METHODS: Twenty patients were randomly selected and equally divided into 2 groups (A and B), with each group of 10 including 6 patients with keloids and 4 with hypertrophic scars. Treatment assignments were random. In group A, the entire scar was treated by skin needling, with silicone gel applied to half of the scar. Patients in group B were treated with silicone gel on the whole scar, with only half of the scar also treated with skin needling. During follow-up visits, clinical photographs, evaluation of the scars' thickness, skin ultrasound, and modified Vancouver Scar Scale were performed. RESULTS: Group A showed an average improvement of 68% (P < .01) on the half of the scar with the combination treatment (skin needling plus silicone gel) compared with a 52% improvement on the half of the scar that was treated with only skin needling. Group B showed an average improvement of 63% (P < .01) where the combination treatment was performed, compared with 47% improvement on the area treated with only the silicone gel. CONCLUSIONS: In conclusion, the combination of these 2 treatments is safe and effective for the treatment of hypertrophic scars and keloids. These modalities achieved favorable results with each patient adhering to the study paramenters.

Evaluating an outreach service for paediatric burns follow up.

Complications following paediatric burns are well documented and care needs to be taken to ensure the appropriate follow up of these patients. Historically this has meant follow up into adulthood however this is often not necessary. The centralisation of burns services in the UK means that patients and their parents may have to travel significant distances to receive this follow up care. To optimise our burns service we have introduced a burns outreach service to enable the patients to be treated closer to home. The aim of this study is to investigate the impact of the introduction of the burns outreach service and within this environment define the optimum length of time needed to follow up these patients. A retrospective analysis was carried out of 100 consecutive paediatric burns patients who underwent surgical management of their burn. During the follow up period there were 43 complications in 32 patients (32%). These included adverse scarring (either hypertrophic or keloid), delayed healing (taking >1 month to heal) and contractures (utilising either splinting or surgical correction). Fifty-nine percent of these complications occurred within 6 months of injury and all occurred within 18 months. Size of burn was directly correlated to the risk of developing a complication. The outreach service reduced the distance the patient needs to travel for follow up by more than 50%. There was also a significant financial benefit for the service as the follow up clinics were on average 50% cheaper with burns outreach than burns physician. Burns outreach is a feasible service that not only benefits the patients but also is cheaper for the burns service. The optimum length of follow up for paediatric burns in 18 months, after which if there have not been any complications they can be discharged.