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

Abstract and Introduction

Abstract

Objective: To determine if the experimental (keratin-based) dressing accelerates epithelialization rates during healing of partial-thickness wounds, relative to a Standard Care dressing.

Method: A randomized control trial was conducted using a Standard Care dressing side by side with the experimental dressing on a sample (n = 26) of partial-thickness donor site wounds. The proximal/distal placement of the control and treatment was randomized. Percentage epithelialization after approximately 7 days was estimated from which time to fully epithelialize can be inferred. Patients were grouped into "young" (≤50 y/o) and "old" (>50 y/o).

Results: For the "old" patients (n = 15), the median epithelialization percentage at 7 days is 5% and was significantly (P = .023) greater for the experimental dressing. For the "young" patients (n = 11), the median epithelialization percentage at 7 days was 80% and there is no significant difference between the experimental and Standard Care control dressings.

Conclusions: The experimental dressing significantly increases the rate of epithelialization of acute, traumatic partial-thickness wounds in older patients. We suggest that the dressing may be clinically useful in similar situations where epithelialization may be delayed because of patient or wound characteristics.

Introduction

Keratinocyte proliferation and migration plays a key role in the reepithelialization of cutaneous wounds. Upregulation of various intermediate filament genes such as Keratins 6, 16, and 17[1] is central to this process. Apart from being important to the structural integrity of skin, these inducible keratins regulate cell growth and migration via the Akt/mTOR signalling pathway.[2] It is thought that the activation of these genes therefore is integral to effective cutaneous wound healing, and Keratin 16 has been shown to be the most down-regulated gene in the bed of nonhealing ulcers when compared with healing wounds.[3] The critical role of Keratin 17 has similarly been shown as the absence of the gene results in markedly impaired healing.[2] Research into exogenous keratins is showing promise in the treatment of cutaneous wounds by stimulating keratinocyte activation, inducing the expression of endogenous keratins, and accelerating reepithelialization.

A new range of keratin-based dressings (Replicine™ by Keraplast, San Antonio, Texas [www.keraplast.com]) have demonstrated the ability to upregulate the migration and proliferation of keratinocyte cells.[4] The constituent keratin protein is (so-called) "Functional" because it retains its structural form and is able to perform its biological function. The dressings have further demonstrated that they can accelerate epithelialization rates of acute, deep partial-thickness wounds in an in-vivo porcine model study[5] and acute wounds in Epidermolysis Bullosa patients[6,7] and in skin-tear injuries.[8] Further clinical studies conducted on chronic wounds (venous leg ulcers) have also observed faster healing rates.[9,10]

Split skin graft donor sites have been shown to respond to moist healing,[11] but a comprehensive meta-analysis[12] did not demonstrate an effect of other factors. Various exogenous growth factors have been investigated and believed to have potential but have not been adopted in standard clinical practice.[13,14]

We aimed to compare epithelization rates achieved by keratin-based dressings with standard wound care for partial-thickness acute wounds in humans in a clinical setting.

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