An innovative, highly conformable, mesh-free healing matrix dressing: results of a clinical trial.

Abstract

<h4>Objective</h4>The aim of this clinical trial was to evaluate the performance and local tolerance of an innovative mesh-free contact layer (healing matrix) made of lipidocolloid technology (TLC) in the management of various wounds. This dressing is made highly flexible by the absence of textile mesh in its core.<h4>Method</h4>A four-week, prospective, multicentre clinical trial was conducted on the evaluated dressing (UrgoFit, Laboratoires Urgo, France) in 23 centres in France. Eligible patients were adults with a cutaneous wound of acute or chronic origin or due to epidermolysis bullosa (EB) in the granulation stage. The primary endpoint was the relative wound area reduction (RWAR) at week 4. Secondary endpoints included wound closure rate and time-to-heal, as well as dressing change frequency, pain at dressing removal, local tolerance and acceptability of the dressing.<h4>Results</h4>A total of 78 adult patients (23-95 years old) were treated with the dressing over a period of 24±8 days. Wound aetiologies included: postoperative or traumatic finger wounds; skin graft donor sites; dermabrasions/skin tears; burns; leg ulcers (LUs) of predominantly venous origin; a stage 3 pressure injury; and EB lesions. The median RWAR at week 4 was 98.2% (ranging between 61.5-100.0%, depending on wound types). Complete closure was achieved in 49% of patients (59% in acute wounds, 60% in EB lesions and 16% in chronic wounds) with a median time-to-heal of 16.5 days (ranging between 14.5-27.0 days, depending on wound types). Half of LUs reached a RWAR ≥40% at week 4, a predictive indicator of complete wound healing at week 24. Dressings were changed every 2±1 days on average (and left in place for a maximum of 10 days). Since the first application, the dressing was judged by healthcare professionals (HCPs) to be 'very easy' or 'easy' to apply on 96% of wounds, with a 'very good' or 'good' conformability to 94% of wound beds. Similar results were reported in cases of finger/hand wounds. Since the first week of treatment, the dressing removal was also judged 'very easy' or 'easy' in 95-98% of the cases, protecting and preserving newly formed tissue in 100% of cases. At the first follow-up visit, patients reported the dressing changes to be painless in 95% of cases. This represented a significant improvement over the previous dressings they received (p<0.0001). In all, seven non-serious adverse events related to the dressing were reported during the study period.<h4>Conclusion</h4>In this clinical trial, the innovative mesh-free TLC dressing was shown to promote wound healing, to be well tolerated and well accepted by patients and HCPs, in line with the evidence available on other TLC dressings; however, its enhanced conformability may provide an additional benefit for the management of wounds.