Suprathel Versus Xeroform for the Management of Skin Graft Donor Sites — Suprathel  

Burns Clinical Trial

Official title: A Randomized Controlled Trial Comparing Suprathel Versus Xeroform for the Management of Pediatric and Adult Split Thickness Skin Graft Donor Sites

Status Terminated

Clinical Trial Summary

The investigators aim to study whether Suprathel, a synthetic temporary skin substitute developed by PolyMedics Innovations GmBH aids in the management of patient pain and wound healing when compared to the current standard dressing used of a primary Xeroform dressing.

Clinical Trial Description

Acute burn and donor site dressing changes are among the most traumatic and painful procedures performed on awake children and adults (7, 8). As a result, it is important to utilize dressings that: 1) stabilize open burn wounds and donor sites; 2) limit the frequency of dressing changes; 3) optimize burn wound and donor site healing; and 4) minimize scarring. Anecdotal evidence and a growing body of literature suggest that Suprathel may offer superior pain control and a decreased frequency of dressing changes, when compared to Xeroform.

At Children's Hospital Colorado, the standard of care is to use Xeroform to dress split thickness skin grafts and donor sites. Xeroform is an inexpensive, bacteriostatic, non-adherent petroleum gauze dressing that is supplied in strips, sheets and rolls. It is used to protect freshly skin grafted areas and donor sites, it is then covered with gauze followed by BandNet. When Xeroform is applied to a split thickness donor site, it adheres to the open wound bed, where it is allowed to dry out. As the donor site heals, the Xeroform begins to separate from the wound bed, until the Xeroform eventually sloughs off.

Suprathel is a biosynthetic dressing developed by PolyMedics Innovations in Germany. Potential advantages to the use of Suprathel include its water solubility, elongation capacity, and porosity, which prevents fluid accumulation at the burn site. In a prior study, Suprathel was associated with favorable burn scar formation (improved Vancouver Scar Scale Scores) and decreased pain with dressing changes. In another study, adolescent and adult burn patients dressed in Suprathel reported significantly less pain than those who were dressed in Mepilex dressings. In post-treatment surveys, patients preferred the use of Suprathel when compared to Mepitel. In a study that compared Suprathel to other standard burn dressings, there was no statistical difference in wound healing, scar formation, and epithelization. Given the limitations in sample size and scarce pediatric data in prior studies, further research is necessary to determine the efficacy of Suprathel in the pediatric population and whether this is a dressing material that should be offered to hospital patients.

New outpatients and inpatients who meet study inclusion criteria and require split-thickness skin grafting, will be randomized into the Suprathel group or the control group on the day of surgery. The investigators will use even calendar operative days for Suprathel and odd calendar operative days for Xeroform. Parental consent and/or patient assent will be obtained prior to the operative procedure. ;

Related Conditions & MeSH terms

• Burns
• Skin Abnormalities
• Skin Graft Complications
• Skin; Deformity

• NCT number: NCT04014400
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Terminated
• Phase: N/A
• Start date: July 7, 2019
• Completion date: July 23, 2020