my personal edition > dermatology other > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Polyurethane Dressing on Hypertrophic Scars in Comparison With a Silicon Sheet: Presented at EADV

By Chris Berrie

VIENNA, AUSTRIA -- May 24, 2007 -- Use of a self-adhesive, hydroactive, polyurethane dressing (Hansaplast® Scar Reducer) is safe and provides significant clinical improvements for the treatment of hypertrophic scars in healthy subjects, according to results of a multicentre, open-label, observer-blind, randomised, intra-individual, comparison study.

The polyurethane dressing was generally better tolerated than the use of a silicone gel sheet, the conventional treatment for scars, the researchers found.

This study was presented here on May 18^th at the 16^th European Academy of Dermatology and Venereology Congress (EADV).

While prevention of hypertrophic scars is preferable to treatment in at-risk patient populations, once a scar is present there are a variety of options for its removal, including intralesional corticosteroid injections, interferon and 5-fluorouracil, surgical therapy, radiotherapy, pulsed-laser therapy, and cryotherapy.

However, for cases of minor problematic scars, the emphasis has recently been on the use of silicone sheets to prevent, or at least reduce, scar hypertrophy. Similarly, more recently the use of a self-adhesive, hydroactive, polyurethane dressing has been shown to improve 1- to 5-year-old scars.

Coinvestigator Maike Kuhlmann, MD, medical and regulatory affairs department, Beiersdorf AG, Hamburg, Germany, and colleagues conducted their study to determine the efficacy and safety of a polyurethane dressing as compared with a silicone sheet.

Sixty healthy subjects with a hypertrophic scar of more than 6 weeks' duration, measuring at least 5 to 10 mm in width and 60 mm in length were enrolled in this study. Exclusion criteria included any topical or invasive therapy.

For the treatments, each scar was divided into 2 areas, and the 2 dressings were randomly assigned 1 to each. One area of the scar was thus treated for 24 hours daily over the 12-week study period with the silicone sheet, and the second area was simultaneously treated with the polyurethane dressing. For evaluation, the observer-blind grading assessments and determination of skin redness were performed on day 1 and at weeks 4, 8, and 12.

The primary endpoint was the overall Scar Index (SI), which includes assessment for colour, matte, contour, distortion, texture, and overall assessment on a Visual Analogue Scale (VAS), as well as specific assessments, including changes from baseline to study visit, and objective determination of skin redness. The assessment also involved subject's perceptions relating to scar colour, prominence, softness, tightness, and discomfort.

In the clinical evaluation, the overall Scar Index score decreased with both the silicone sheet and polyurethane dressing, although a better score was seen with the polyurethane dressing.

Over the full 12-week period, the polyurethane dressing showed significant noninferiority (P <.0001) compared with the silicone sheet. At weeks 4 and 8, the decrease in overall Scar Index score was more pronounced for the polyurethane dressing. Indeed, the polyurethane showed a significantly greater overall score at week 4 (P <.0001), which carried through to week 8 (P <.012), but which was lost by week 12.

Chromameter measurements for redness showed a slight decrease with both treatments, again in favour of the polyurethane dressing; however, this difference reached significance only at week 8 (P =.0016).

Patients judged that the scar prominence was exactly the same with the 2 treatments, but all the other parameters -- colour, softness, tightness, and annoyance -- were in favour of the polyurethane dressing.

During the full trial period, no serious adverse events were reported. However, there were 2 adverse events associated with the silicone sheets (local dermatitis). Conversely, no adverse events were recorded that were related to the use of the polyurethane dressing.

Lively debate continues around the benefits of many common treatments to prevent and/or treat hypertrophic scars, according to the researchers. In this study, both treatment groups showed benefits according to the clinical Scar Index. However, the polyurethane dressing did demonstrate significantly pronounced decreases in clinical signs after 4 and 8 weeks of treatment and it was generally better tolerated compared with the silicone sheet, the researchers concluded.

This study was sponsored by Beiersdorf AG, Hamburg.

[Presentation title: Efficacy of a Polyurethane Dressing on Hypertrophic Scars in Comparison to a Silicon Sheet. Abstract P50]

E-Mail this DGDispatch to a colleague

To print, use this version