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Non‐interventional study to investigate the efficacy and safety of Tegaderm™ Matrix in the treatment of patients with therapy‐refractory chronic wounds
Author(s) -
Weindorf Maren,
Körber Andreas,
Klode Joachim,
Dissemond Joachim
Publication year - 2012
Publication title -
jddg: journal der deutschen dermatologischen gesellschaft
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.463
H-Index - 60
eISSN - 1610-0387
pISSN - 1610-0379
DOI - 10.1111/j.1610-0387.2011.07828.x
Subject(s) - medicine , refractory (planetary science) , adverse effect , wound healing , surgery , chronic wound , physics , astrobiology
Summary Background: Despite a variety of therapeutic approaches, many patients with chronic wounds remain refractory to treatment. Products such as Tegaderm™ Matrix were developed especially for such patients to alter the wound environment and reactivate the stagnant wound healing process. Patients and Methods: In this prospective post‐authorization observational product study, a total of 314 patients with therapy‐refractory chronic wounds of various origins were evaluated. Beside to the wound area reduction and healing rate, the occurrence of adverse events was documented. Results: On average the wounds were 10 months old. The average wound size was 17.3 cm 2 (median 6.3 cm 2 ) at the initial visit. In the course of treatment the wound size decreased to 13.0 cm 2 (median 3.5 cm 2 ) and was finally reduced to 9.3 cm 2 (median 0.9 cm 2 ) at end of the study. Taking the criteria of the European Wound Management Association for improving the quality of clinical studies into consideration, a wound size reduction of at least 50 % is the parameter for successful treatment of chronic wounds. This study demonstrated a wound size reduction of at least 50 % for 72.9 % of the patients with therapy‐refractory chronic wounds when treated with Tegaderm™ Matrix. The safety profile was evaluated; only 4.7 % of the patients experienced a treatment‐related adverse event such as a burning sensation. Conclusions : The results of the study demonstrate that Tegaderm™ Matrix along with treatment of underlying causes is a well tolerated wound dressing promoting wound size reduction up to healing for the majority of patients with previously therapy‐refractory chronic wounds.

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