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Clinical Research
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Hydrofiber Dressing with Silver in the Management of Split-thickness Donor Sites First Author: S. Blome-Eberwein, MD Authors: M. Johnson, MD, G. Fudem, MD, D. Caruso, MD, M. H. Jordan, MD, S. Milner, MD, S. F. Miller, MD, E. E. Tredget, MD, K. Sittig, MD, L. Smith, DO Introduction: Previous studies have shown the effectiveness of a Hydrofiberª dressing with silver (HDS) in partial thickness burns. In addition, many physicians have also adopted HDS in the management of donor sites. A multi-center prospective randomized clinical trial was conducted to demonstrate opportunities for usage in this indication. Methods: This study evaluated two HDS protocols of care to manage donor sites on the anterior thigh: one using a film dressing cover to maintain a gelled state, the other using a gauze dressing enabling an adherent state. Both protocols required a mandatory dressing change at 24-48 hours post-op with subsequent assessments at days 5, 10, 14 and 21. The primary objective of the study was to assess the proportion of subjects healed (90%-100% reepithelialized) by visit day 14. Secondary endpoints included safety, pain, resource utilization, and clinical acceptability. Results: A total of 70 subjects were randomized and treated from 9 centers within the US and Canada. Subjects in both groups were similar in age, gender and reason for grafting. The average donor site size was 308 cm2. 77% of all subjects had healed by visit day 14; 88% in the gelled group and 67% in the adherent group. There were no treatment related serious adverse events reported. Three subjects experienced adverse events considered related to treatment; skin irritation, redness and one suspected infection. In both groups resource utilization was minimized with an average of 2 dressing changes during the study, one of which was mandatory. Investigating clinicians preferred a HDS protocol to their current practice in five of six areas: Speed of healing, quality of healing, comfort during wear, pain during dressing change, and overall simplicity. Management as an outpatient was equivalent. Pain measured during rest and mobility using a visual analog scale (1-10) with the gelled group illustrated clinically significant results. Conclusions: This study demonstrated that HDS is clinically effective and versatile in the management of donor sites with the majority of investigators favoring a HDS protocol to their current regimen. |
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