An Open, Noncomparative, Clinical Follow-up Study to Confirm Performance and Safety of a Gelling Fiber Dressing When Used on Split-thickness Skin Graft Donor Sites.

Abstract

Objective: The performance of a gelling fiber dressing (GFD) was evaluated in adult patients undergoing split-thickness skin graft (STSG) transplantation.

Methods: A gelling fiber dressing was applied directly to the donor sites; a soft-silicone-coated foam was used as the secondary dressing. Follow-ups were scheduled for days 3 and 14, and day 21 for patients with donor sites that had not healed. The primary outcome measure was donor site progression from baseline to last visit when GFD was used. Secondary outcome measures included clinicians' and patients' evaluations of GFD performance, patients' evaluations of pain severity, dressing wear time, and adverse events.

Results: Twenty-nine of 33 participants (87.9%) had donor sites considered as "improved" at the final visit. Twenty (60.6%) donor sites were healed during the period when the GFD was used. High percentages of "good"/"very good" clinicians' ratings for the ability of GFD to absorb/retain exudate (93.3%), absorb/retain blood (96.6%), conform to the wound bed (96.8%), and maintain integrity when wet on removal (100%) were recorded. High percentages of "good"/"very good" patient ratings for comfort during wear (93.9%) and experience during dressing changes (86.6%) were also recorded. Mean pain score at GFD removal was 1.3, on a scale from 0 = no pain to 10 = worst imaginable. Median wear time per individual dressing was 14 days. Four adverse device events were reported.

Conclusions: The findings indicate the suitability of GFD for donor site management. The dressing, rated highly by clinicians and patients, was associated with good healing progression.