Abstract
BackgroundIn many clinical trials on cutaneous healing, wound closure is the primary endpoint and single most important outcome parameter, making precise assessment of this time point one of utmost importance. The assessment of wound closure can be performed either by subjective clinical inspection or with a variety of methodologies anticipated to provide more objective data. The aim of this study was to examine intra- and interrater variability of blinded photographic analysis of wound closure of human partial thickness wounds, as well as the reliability of remote photographic analysis of wounds with that of direct clinical assessment.MethodsTwo plastic surgeons, a dermatologist, and a maxillofacial surgeon constituted our rater panel. High-resolution images of patient wounds derived from two randomized controlled clinical trials (EU Clinical Trials Register numbers EudraCT 2009-017418-56 (registered 12 January 2010) and EudraCT 2010-019945-24 (registered 13 July 2010)) were individually assessed by the blinded, experienced study raters. The reliability of photographic image analysis was tested using intraclass and interclass correlation. The validity of photographic image analysis was correlated with clinical assessments of documented time to heal from the study centers’ files.ResultsThe results demonstrated that the mean intraclass correlation coefficient of all four examiners was excellent (r = 0.79; 95 % confidence interval (CI), 0.61, 1.00)). The interrater correlation coefficient was good (r = 0.67; 95 % CI, 0.57, 1.00)) and therefore acceptable. The agreement between remote visual assessment and clinical assessment at the time of healing was good (r = 0.64; 95 % CI, 0.52, 0.76)) with an overall difference of about 1 day.ConclusionsRemote photographic analysis of cutaneous wounds is a feasible instrument in clinical open-label studies to evaluate time to wound closure. We found that it was a reliable method of measuring wound closure that correlated satisfactorily with clinical judgment, bolstering the potential relevance in the current era of evolving application and dependency in the field of telemedicine.Trial registrationEU Clinical Trials Register EudraCT numbers 2009-017418-56 (date of registration: 12 January 2010) and 2010-019945-24 (date of registration: 13 July 2010).
Highlights
In many clinical trials on cutaneous healing, wound closure is the primary endpoint and single most important outcome parameter, making precise assessment of this time point one of utmost importance
Study design We performed a secondary analysis of data obtained from two prospective, open-label randomized controlled clinical trials in which researchers assessed the effect of a triterpene extract from birch cork on wound healing
The first study was performed on split-thickness skin graft donor sites, with each donor site divided into halves and one half treated with a nonadhesive foam dressing (Mepilex; Mölnlycke Health Care, Gothenburg, Sweden) alone and the other half treated with Oleogel-S10 ointment (Birken AG, Niefern-Öschelbronn, Germany) covered by Mepilex (EudraCT number: 2009017418-56; ClinicalTrials.gov identifier: NCT01294254; ethics committee of the Ernst Moritz Arndt University, Greifswald, Germany; Ethics Committee of the Albert Ludwigs University, Freiburg, Germany)
Summary
In many clinical trials on cutaneous healing, wound closure is the primary endpoint and single most important outcome parameter, making precise assessment of this time point one of utmost importance. A similar challenge results when evaluating other promoted objective measurements of epithelialization such as electrical impedance [2] and transepidermal water loss [3], among others. Even with these quantitative modalities, identifying and choosing a region of interest may not necessarily represent the whole of the wound area. Blinding of the evaluating clinicians at the study site is often intricate or even impossible
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