Epidermal Grafting in Wound Healing

Not Applicable

Completed

Interventions: Procedure: Split thickness skin grafting
Device: Epidermal grafting

Brief Summary: Split thickness skin grafting is the normal standard of care for wound closure. However, this is an invasive procedure and associated with pain also there can be additional donor site morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that 'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This potentially results in less pain and reduced donor site morbidity but only delivers several cell layers to the wound so may be less effective at healing a wound. It is not known if EG is an effective alternative to SSG.

Further the mechanism to achieve wound healing may be different. EG promotes wound healing by expressing growth factors that accelerates wound healing and encourages keratinocyte migration. Whereas SSG is a transplant of several skin layers that integrated to the existing wound bed as a formal skin covering.

The investigators wish to compare these two clinical practises; epidermal grafting and split thickness skin grafting in wound healing. Further to undertake a translational study to investigate the mechanism by which each technique achieves wound healing.

Detailed Description: This study evaluates the efficacy of EG, as an alternative to current wound management therapy, SSG. In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site. Moreover, complete wound epithelialisation was achieved while maintaining patient independence. Therefore, this device has the potential to save healthcare resources, by eliminating the need for theatre space and a hospital bed, and result in better Patient Reported Outcomes Measures.

Recruitment & Eligibility

Inclusion Criteria

Male or female
Age 18-90
Wound measuring more than 1cm x 1cm and lesser than 5cm x 5cm (1% TBSA)
Wound with clean, healthy granulating bed, with minimal adherent slough
Patient understands and is willing to participate and can comply with weekly visits and follow-up regime

Exclusion Criteria

Wound with active infection
Wound at plantar of the foot
Patients unsuitable for Split Skin Grafting
Previous history of excessive bleeding associated with surgical biopsies or trauma
Allergies to tegaderm (and other dressings used in the study)
Known uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%.
Presence of one or more medical conditions, including renal, hepatic, hematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study
Patient not fit for surgery (ASA classification > 4)

Arm && Interventions

Group	Intervention	Description
Split Thickness Skin Graft	Split thickness skin grafting	Split thickness skin graft will be harvested using air dermatome as per normal clinical practise.
Epidermal Graft	Epidermal grafting	The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts as per existing normal clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Wounds With Complete Healing	6 weeks and 3 months	Number of wounds with complete healing at 6 weeks
Mean Time for Donor Site Healing	3 months	Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings

Secondary Outcome Measures

Name	Time	Method
Time for Wound Healing	3 months	Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings
Donor Site Morbidity	6 weeks and 3 months	The donor site morbidity was measured using the Vancouver Scar Scale (VSS). Total score scale ranges from 0 to 13. Lower score is more desirable as it represents a scar resembling normal surrounding skin. The scale assesses 4 categories: vascularity, height, pliability, and pigmentation. Total score is obtained by the sum of the categories.
Patient Reported Outcome Measure (PROM)	6 weeks and 3 months	Patient reported outcome measure was assessed using a validated skin graft satisfaction questionnaire.The skin graft satisfaction questionnaire has a scale ranging from 1 to 7, with 1 representing very unsatisfied while 7 represents very satisfied. Hence, higher score represent higher satisfaction.
Adverse Events	3 months	Number of participants with of adverse events