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).

[ASSESSMENT OF COMBINED PROPHYLAXIS OF PATHOLOGICAL POSTOPERATIVE FACE SKIN SCARS ACCORDING TO THE VANCOUVER SCALE].

The aim of the research was to study the effectiveness of combined prophylaxis of pathological postoperative face skin scars according to the Vancouver scale. The research involved 29 patients, aging 16-48 years old, who underwent maxillofacial surgery by extraoral accesses with wound primary intention healing. The patients were divided into three groups: the control group, which involved the patients, who after the surgery did not undergo any preventive measures to avoid pathological skin scars development, and two study groups. The patients of the first study group underwent the monotherapy comprising three sessions of extracorporeal shock wave therapy once every 4-5 days. The patients of the second study group underwent three sessions of extracorporeal shock wave therapy once every 4-5 days and local use of silicone gel Strataderm. The Vancouver scale was used to evaluate clinically the effectiveness of the suggested methods of pathological scars development prevention. It involved evaluation (in points) of their consistency, pigmentation, and vascularization. The scars were assessed on the 7th, 30th day after the surgery and in 6 months. Positive results were attained in the patients of both study groups; they were manifested by increased elasticity and compliance of scars, pigmentation becoming of just about surrounding skin natural color, normalization of blood supply to scars, and more rapid disappearance of suture marks. However, these positive signs were more significant in the patients of the second study group that allowed us concluding that combined use of extracorporeal shock wave therapy and local applying of silicone gel Strataderm was advisable.

Use of Patient and Observer Scar Assessment Scale for evaluation of facial scars treated with self-drying silicone gel.

In this prospective study, we used the Patient and Observer Scar Assessment Scale (POSAS) to evaluate the outcome of the healing process of posttraumatic and surgical facial scars that were treated with self-drying silicone gel, by both the patient and the observer. In our division, the application of base cream and massage represents the standard management of facial scars after suture removal. In the current study, 15 patients (7 men and 8 women) with facial scars were treated with self-drying silicone gel that was applied without massage, and 15 patients (8 men and 7 women) were treated with base cream and massage. Both groups underwent a clinical evaluation of facial scars by POSAS at the time of suture removal (T0) and after 2 months of treatment (T1). The patient rated scar pain, itch, color, stiffness, thickness, and surface (Patient Scale), and the observer rated scar vascularity, pigmentation, thickness, relief, pliability, and surface area (Observer Scale [OS]). The Patient Scale reported the greatest improvement in the items color, stiffness, and thickness. Itch was the only item that worsened in the group self-drying silicone gel. The OS primarily reported an improvement in the items vascularization, pigmentation, and pliability. The only item in the OS that underwent no change from T0 to T1 was surface area. The POSAS revealed satisfactory healing of posttraumatic and surgical facial scars that were treated with self-drying silicone gel.