Photoplanimetric evaluation and impedance measurement of split-thickness skin grafts: a new model for objective wound-healing assessment in clinical trials.
OBJECTIVE
The objective assessment of wound healing is a challenging task especially in the context of clinical trials. Because the clinical evaluation of wounds and the wound-healing quality is often influenced by the subjective view of the physician, there is great need for a reliable, quantitative and objective wound model that would help to obtain statistically useful data. Here, we present a wound model and non-invasive analysis techniques to evaluate human wound healing. The model described was used in a clinical trial on 167 patients treated with a new wound therapeutic agent.


METHODS
The study was conducted on 167 patients receiving split-thickness mesh grafts (1 : 1.5 and 0.1 mm) after reconstructive procedures. The re-epithelialization of the mesh holes and the leakage of wound serum served as the main parameters of wound healing. The quantitative evaluation of the epithelialization rate was performed by photoplanimetry and impedance measurement. These data were correlated with the clinical wound assessment of two independent physicians.


RESULTS
The study showed that computer-aided photoplanimetry, in combination with impedance measurement, is a feasible and very useful method to evaluate the re-epithelialization rate of mesh skin grafts.


CONCLUSIONS
The model described is a viable method to evaluate human wound healing in clinical trials.
Hauser
J
J
Department of Plastic and Hand Surgery, Burn Center, University Hospital Bergmannsheil, Ruhr-University-Bochum, Bochum, Germany. joerg.hauser@rub.de
Lehnhardt
M
M
Daigeler
A
A
Langer
S
S
Steinau
H U
HU
Vogt
P M
PM
D002986:Clinical Trials as Topic / Q000379:methods; D046169:Dermoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010992:Plethysmography, Impedance / Q000379:methods*; D012867:Skin / Q000473:pathology* / Q000503:physiopathology*; D016038:Skin Transplantation / Q000379:methods* / Q000473:pathology*; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology*