Do Functional Keratin Dressings Accelerate Epithelialization in Human Partial Thickness Wounds?

A Randomized Controlled Trial on Skin Graft Donor Sites

Andrew Davidson, MBChB; N. Hamesh Jina, MBChB; Clive Marsh, PhD; Martin Than, MBBS; Jeremy W. Simcock, MD

Disclosures

ePlasty. 2013;13 

In This Article

Methods

Setting and Participants

We enrolled consenting adult patients undergoing a split skin graft as part of reconstructive surgery. The split skin graft donor site was the thigh in all cases except one where it was taken from the medial arm. The thickness of skin graft harvested was determined by the reconstructive need (typically 10/1000-in thick).

Study Design

This was a randomized controlled trial in which part of the graft donor site was used as an internal control for each individual patient. The donor site wound was dressed half with a control dressing and half with an experimental (keratin) dressing. The proximal or distal location of each dressing type (control or experimental) was determined using sequential prerandomized, sealed, opaque envelopes. Split skin graft donor site wounds were chosen for this study, because they provide uniform thickness wounds for making epithelialization rate comparisons. In addition, they are sufficiently large to allow Treatment and Control dressings to be used side by side to provide an internal control for each patient.

Control Dressing

This was an alginate dressing (Algisite [Smith and Nephew, London]), applied postsurgery, and left in-situ for 2 weeks (at which time complete healing is expected to have occurred). This was standard care for donor sites at our facility.

Experimental Dressing

Keramatrix® (Keraplast, San Antonio, TX) is one of the dressings in the Replicine™ keratin dressing range. This was chosen as the Treatment for the study because its exudate handling properties and longevity matched the needs of a skin graft donor site.

Outcome Measurement

The primary outcome was the extent (percentage) of epithelialization in proximal and distal thirds of the wound at 7 days after surgery. The middle third of the wound was ignored as it potentially may have been influenced by both dressings. The percentage epithelialization was estimated by an experienced clinician, blinded to treatment allocation who made visual assessments in controlled lighting conditions in clinic. Photographs were taken for reference but do not reliably discriminate neoepithelium from sheen of wound moisture.

Secondary assessment was by a questionnaire completed by outpatient department nurses at the time of 7-day follow-up. They were asked to assess each half of the dressing for ease of removal and pain on removal.

Statistical Methods

A 2-tailed, paired, t-test approach was used to determine if there were significant differences between the percentage epithelization levels of the Treatment and Control portions of each donor site. Patients older than 50 years and those 50 years old or younger were analyzed as separate groups.

The study was approved by the institutional review board (Upper South B Regional Ethics Committee, New Zealand). The approved study protocol described the data and subgroup analysis plan.

processing....