Clinical trial NCT02535481: Epidermal Grafting in Wound Healing
Official title: A Multi-centre Randomised Controlled Trial to Compare Epidermal Grafting With Split Skin Grafting for Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer
Skin Ulcer
Wounds and Injuries
Keywords: epidermal graft
suction blister
blister graft
suction graft
Epidermis/su, tr [Surgery, Transplantation]
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Wound with active infection
2. Wound at plantar of the foot
3. Patients unsuitable for Split Skin Grafting
4. Previous history of excessive bleeding associated with surgical biopsies or trauma
5. Allergies to tegaderm (and other dressings used in the study)
6. Known uncontrolled Diabetes Mellitus, as measured by an HbA1c \> 10%.
7. 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
8. Patient not fit for surgery (ASA classification \> 4)

Primary outcomes:
measure: Number of Wounds With Complete Healing
timeFrame: 6 weeks and 3 months
measure: Mean Time for Donor Site Healing
timeFrame: 3 months
Secondary outcomes:
measure: Time for Wound Healing
timeFrame: 3 months
measure: Donor Site Morbidity
timeFrame: 6 weeks and 3 months
measure: Patient Reported Outcome Measure (PROM)
timeFrame: 6 weeks and 3 months
measure: Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hampstead NHS Trust Hospital
Study officials:
affiliation: University College, London
name: Toby Richards, MD FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Free Hospital NHS Foundation Trust
name: Afshin Mosahebi, MBBS FRCS PhD MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanapathy M, Bystrzonowski N, Hachach-Haram N, Twyman L, Becker DL, Richards T, Mosahebi A. Lower donor site morbidity and higher patient satisfaction with epidermal grafting in comparison to split thickness skin grafting: A randomized controlled trial (EPIGRAAFT Trial). J Plast Reconstr Aesthet Surg. 2020 Aug;73(8):1556-1564. doi: 10.1016/j.bjps.2020.03.006. Epub 2020 Mar 16.
citation: Kanapathy M, Hachach-Haram N, Bystrzonowski N, Harding K, Mosahebi A, Richards T. Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial. Trials. 2016 May 17;17(1):245. doi: 10.1186/s13063-016-1352-y.