Trial Outcomes & Findings for RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction (NCT NCT04091672)

Last Updated: 2024-07-30

Results Overview

The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas (Investigational Intervention) as compared to Control areas (Control Intervention). Healing is defined as complete wound closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Prior to or at 8 weeks

Results posted on

2024-07-30

Participant Flow

The design of this study is a within-patient comparison. Protocol enrollment is 65 (participants), with 130 interventions (2 per participant).

Unit of analysis: wound treatment areas

Participant milestones

Participant milestones
Measure	Control Intervention After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings)	Investigational Intervention (RECELL) After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings).
Overall Study STARTED	65 65	65 65
Overall Study COMPLETED	47 47	47 47
Overall Study NOT COMPLETED	18 18	18 18

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Intervention After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings)	Investigational Intervention (RECELL) After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings).
Overall Study Death	6	6
Overall Study Lost to Follow-up	7	7
Overall Study Withdrawal by Subject	3	3
Overall Study Non-Compliance With Study Schedule	2	2

Baseline Characteristics

RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: All Participants (Within Patient Control) n=65 Participants All subjects will receive both RECELL and skin graft. Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B
Age, Continuous	45.7 years STANDARD_DEVIATION 18.3 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to or at 8 weeks

Population: Per protocol

Outcome measures

Outcome measures
Measure	Control Intervention n=52 Treatment Areas After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings)	Investigational Intervention (RECELL) n=52 Treatment Areas After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings).
Incidence of Treatment Area Healing	30 Treatment Areas	34 Treatment Areas

PRIMARY outcome

Timeframe: Treatment Day

Population: ITT

The donor skin expansion achieved with treatment using RECELL and widely meshed autograft (Investigational Intervention) is hypothesized to be superior to the donor skin expansion ratio achieved with conventional autograft treatment (Control Intervention). Expansion ratio, computed as the ratio of measured treated area to the measured donor site area, is calculated separately for each Intervention (including any donor skin needed for repeat treatments).

Outcome measures

Outcome measures
Measure	Control Intervention n=65 Study Areas After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings)	Investigational Intervention (RECELL) n=65 Study Areas After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings).
Donor Skin Area to Treatment Area Expansion Ratio	1.39 Expansion Ratio Standard Deviation 0.44	1.86 Expansion Ratio Standard Deviation 0.47

Adverse Events

Control Intervention

Serious events: 2 serious events

Other events: 35 other events

Deaths: 6 deaths

Investigational Intervention (RECELL)

Serious events: 2 serious events

Other events: 33 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Control Intervention n=65 participants at risk After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings)	Investigational Intervention (RECELL) n=65 participants at risk After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings).
General disorders Impaired Healing	3.1% 2/65 • Number of events 2 • 26 Weeks	3.1% 2/65 • Number of events 2 • 26 Weeks
Infections and infestations Local Soft Tissue Infection	3.1% 2/65 • Number of events 2 • 26 Weeks	3.1% 2/65 • Number of events 2 • 26 Weeks
Infections and infestations Other Infection	3.1% 2/65 • Number of events 2 • 26 Weeks	3.1% 2/65 • Number of events 2 • 26 Weeks
Injury, poisoning and procedural complications Graft Loss	1.5% 1/65 • Number of events 1 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks
Injury, poisoning and procedural complications Skin Graft Failure	1.5% 1/65 • Number of events 1 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks
Injury, poisoning and procedural complications Suture Related Complication	0.00% 0/65 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks
Product Issues Device Malfunction	1.5% 1/65 • Number of events 1 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks

Other adverse events

Other adverse events
Measure	Control Intervention n=65 participants at risk After preparation for autografting, a portion of each participant's wound is randomly assigned to receive the Control Intervention (within-patient control). Conventional Autografting: Meshed split-thickness skin grafting according to a pre-specified grafting plan, along with standardized post-operative wound dressings (Telfa™ Clear and Xeroform™ wound dressings)	Investigational Intervention (RECELL) n=65 participants at risk After preparation for autografting, a portion of each participant's wound is randomly allocated to receive the Investigational Intervention. RECELL plus More Widely Meshed Autograft: A split-thickness skin graft meshed more widely than the pre-specified grafting plan (Control Intervention), plus RECELL, with standardized wound dressings (Telfa™ Clear and Xeroform™ wound dressings).
Injury, poisoning and procedural complications Skin Graft Failure	1.5% 1/65 • Number of events 1 • 26 Weeks	0.00% 0/65 • 26 Weeks
Injury, poisoning and procedural complications Skin Graft Scar Contracture	1.5% 1/65 • Number of events 1 • 26 Weeks	0.00% 0/65 • 26 Weeks
Injury, poisoning and procedural complications Soft Tissue Foreign body	1.5% 1/65 • Number of events 1 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks
Injury, poisoning and procedural complications Wound Decomposition	9.2% 6/65 • Number of events 7 • 26 Weeks	6.2% 4/65 • Number of events 4 • 26 Weeks
Injury, poisoning and procedural complications Wound Necrosis	1.5% 1/65 • Number of events 1 • 26 Weeks	0.00% 0/65 • 26 Weeks
Injury, poisoning and procedural complications Wound Secretion	1.5% 1/65 • Number of events 1 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks
Skin and subcutaneous tissue disorders Blister	1.5% 1/65 • Number of events 1 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks
Skin and subcutaneous tissue disorders Excessive Granulation Tissue	12.3% 8/65 • Number of events 8 • 26 Weeks	18.5% 12/65 • Number of events 12 • 26 Weeks
Skin and subcutaneous tissue disorders Pruritus	4.6% 3/65 • Number of events 3 • 26 Weeks	4.6% 3/65 • Number of events 3 • 26 Weeks
Skin and subcutaneous tissue disorders Rash	1.5% 1/65 • Number of events 1 • 26 Weeks	3.1% 2/65 • Number of events 2 • 26 Weeks
General disorders Impaired Healing	21.5% 14/65 • Number of events 14 • 26 Weeks	18.5% 12/65 • Number of events 12 • 26 Weeks
Infections and infestations Local Soft Tissue Infection	4.6% 3/65 • Number of events 4 • 26 Weeks	6.2% 4/65 • Number of events 5 • 26 Weeks
Injury, poisoning and procedural complications Fall	1.5% 1/65 • Number of events 1 • 26 Weeks	1.5% 1/65 • Number of events 1 • 26 Weeks
Injury, poisoning and procedural complications Graft Loss	12.3% 8/65 • Number of events 8 • 26 Weeks	9.2% 6/65 • Number of events 6 • 26 Weeks
Skin and subcutaneous tissue disorders Skin Exfoliation	6.2% 4/65 • Number of events 4 • 26 Weeks	7.7% 5/65 • Number of events 5 • 26 Weeks

Additional Information

SVP Global Clinical Research

AVITA Medical

Phone: 1-833-462-8482

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER