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.

No comparator group was used, so the study cannot show that the dressing regimen improved healing or comfort more than usual care. It was a single-site study, so results may not generalize. Wound progress and healing were judged subjectively by study staff, and healing was assessed only when dressings were removed, often at day 14. Because most dressings were left in place for 14 days, healing before day 14 was not observed for 30 of 33 participants. Follow-up stopped at day 21, so some participants were not followed until full donor-site healing. Removal was not uniformly easy: 11 (35.5%) were rated poor, and staff moistened the dressing before removal for all but one. Five of 38 enrolled participants did not complete the study. The manufacturer/sponsor was closely involved in data systems, access, and product liability insurance.

Mölnlycke Health Care, the gelling fiber dressing manufacturer, was the sponsor: it provided the electronic case report form, had controlled access to study records, and held product liability insurance for the devices. The supplied text does not include a separate funding or conflict-of-interest declaration.

Do not conclude that the gelling fiber dressing, foam, and tape or bandage regimen is better than standard donor-site care. This was a single-arm study with no comparator, subjective wound assessments, and most dressings left in place until day 14, so the study cannot separate the regimen's contribution from expected healing and routine postoperative care.