Trial Outcomes & Findings for Epidermal Grafting in Wound Healing (NCT NCT02535481)

Results Overview

Number of wounds with complete healing at 6 weeks

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

6 weeks and 3 months

Results posted on

2020-08-10

Participant Flow

A total of 61 patients were screened for eligibility; 44 of them fulfilled the inclusion criteria and were randomized to the two study groups (EG and SSG) between October 2015 and September 2017. Participants were recruited at the Royal Free London NHS Foundation Trust Hospital.

Participant milestones

Participant milestones
Measure	Epidermal Graft Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
Overall Study STARTED	22	22
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidermal Graft n=22 Participants Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft n=22 Participants Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.	Total n=44 Participants Total of all reporting groups
Age, Continuous	58.1 years STANDARD_DEVIATION 19.9 • n=22 Participants	59 years STANDARD_DEVIATION 18 • n=22 Participants	58.7 years STANDARD_DEVIATION 19 • n=44 Participants
Sex: Female, Male Female	9 Participants n=22 Participants	5 Participants n=22 Participants	14 Participants n=44 Participants
Sex: Female, Male Male	13 Participants n=22 Participants	17 Participants n=22 Participants	30 Participants n=44 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Wound size (cm^2)	12.7 cm^2 STANDARD_DEVIATION 9.9 • n=22 Participants	16.5 cm^2 STANDARD_DEVIATION 11 • n=22 Participants	14.6 cm^2 STANDARD_DEVIATION 10.7 • n=44 Participants
Duration of wound (week)	48.9 week STANDARD_DEVIATION 75.4 • n=22 Participants	7.86 week STANDARD_DEVIATION 16.1 • n=22 Participants	28.4 week STANDARD_DEVIATION 58.3 • n=44 Participants

PRIMARY outcome

Timeframe: 6 weeks and 3 months

Number of wounds with complete healing at 6 weeks

Outcome measures

Outcome measures
Measure	Epidermal Graft n=22 Number of wounds Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft n=22 Number of wounds Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
Number of Wounds With Complete Healing 3 months	16 number of wounds	20 number of wounds
Number of Wounds With Complete Healing 6 weeks	9 number of wounds	13 number of wounds

PRIMARY outcome

Timeframe: 3 months

Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings

Outcome measures

Outcome measures
Measure	Epidermal Graft n=22 Participants Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft n=22 Participants Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
Mean Time for Donor Site Healing	4.86 days Interval 4.41 to 5.32	21.32 days Interval 15.65 to 26.99

SECONDARY outcome

Timeframe: 3 months

Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings

Outcome measures

Outcome measures
Measure	Epidermal Graft n=22 Participants Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft n=22 Participants Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
Time for Wound Healing	7.81 week Interval 6.44 to 9.19	6.59 week Interval 5.29 to 7.89

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Epidermal Graft n=22 Participants Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft n=22 Participants Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
Donor Site Morbidity 6 weeks	0.14 unit of a scale Standard Deviation 0.45	3.73 unit of a scale Standard Deviation 0.69
Donor Site Morbidity 3 months	0.09 unit of a scale Standard Deviation 0.29	2.91 unit of a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Epidermal Graft n=22 Participants Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft n=22 Participants Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
Patient Reported Outcome Measure (PROM) 6 weeks	7 score on a scale Interval 7.0 to 7.0	6 score on a scale Interval 5.0 to 7.0
Patient Reported Outcome Measure (PROM) 3 months	7 score on a scale Interval 7.0 to 7.0	6 score on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: 3 months

Number of participants with of adverse events

Outcome measures

Outcome measures
Measure	Epidermal Graft n=22 Participants Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts.	Split Thickness Skin Graft n=22 Participants Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice.
Adverse Events	0 participants	0 participants

Adverse Events

Epidermal Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Split Thickness Skin Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

EPIGRAAFT Trial team

UCL

Phone: 020 7679 2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place