Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix

• ClinicalTrials.gov Identifier: NCT02469168
• Recruitment Status: Terminated
• First Posted: June 11, 2015
• Results First Posted: April 3, 2018
• Last Update Posted: August 7, 2018
• Sponsor: Rubin, J. Peter, MD
• Collaborator: University of Pittsburgh
• Information provided by (Responsible Party): Leon Nesti, Walter Reed National Military Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Wounds and Injury
• Interventions: Device: Recell; Procedure: Control
• Enrollment: 1

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	ReCell	Control
Arm/Group Description	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
Period Title: Overall Study
Started	1	0
Completed	0	0
Not Completed	1	0
Reason Not Completed
Trial closed	1	0

Baseline Characteristics

Arm/Group Title		ReCell	Control	Total
Arm/Group Description		Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix	Total of all reporting groups
Overall Number of Baseline Participants		1	0	1
Baseline Analysis Population Description		did not enroll any additional participants
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1 participants	0 participants	1 participants
		29 (0)		29 (0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	0 participants	1 participants
	Female	0 0.0%		0 0.0%
	Male	1 100.0%		1 100.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	0 participants	1 participants
	American Indian or Alaska Native	0 0.0%		0 0.0%
	Asian	0 0.0%		0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%		0 0.0%
	Black or African American	0 0.0%		0 0.0%
	White	1 100.0%		1 100.0%
	More than one race	0 0.0%		0 0.0%
	Unknown or Not Reported	0 0.0%		0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	1 participants	0 participants	1 participants
		1		1

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Event
Description	Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study
Time Frame	Prior to or at 12 weeks

Outcome Measure Data

Analysis Population Description

did not enroll any additional participants

Arm/Group Title	ReCell	Control
Arm/Group Description:	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
Overall Number of Participants Analyzed	1	0
Measure Type: Count of Participants; Unit of Measure: Participants
	1 100.0%	0

2. Secondary Outcome

Title	Number of Participants With Confirmed Treatment Area Closure
Description	Complete wound closure is defined as skin wound re-epithelialization at 95% or greater at treated wound site and donor sites confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.
Time Frame	Prior to or at 6 weeks

Outcome Measure Data

Analysis Population Description

did not enroll any additional participants

Arm/Group Title	ReCell	Control
Arm/Group Description:	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
Overall Number of Participants Analyzed	1	0
Measure Type: Count of Participants; Unit of Measure: Participants
	1 100.0%	0

Adverse Events

Time Frame	6 weeks and 24 weeks post-operation
Adverse Event Reporting Description	Do not differ from clinicaltrials.gov definitions.
Arm/Group Title	ReCell		Control
Arm/Group Description	Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Recell: ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix		Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Control: Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
All-Cause Mortality
	ReCell		Control
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1/1 (100.00%)		0/0
Serious Adverse Events
	ReCell		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0.00%)		0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ReCell		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/1 (100.00%)		0/0
Surgical and medical procedures
Graft Sloughing †	1/1 (100.00%)	1	0/0	0
Malodorous wound †	1/1 (100.00%)	1	0/0	0
Exudate around graft †	1/1 (100.00%)	1	0/0	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Jody Richardson, MSN, RN
• Organization: Walter Reed National Military Medical Center
• Phone: 301-295-7798
• EMail: jody.richardson.ctr@usuhs.edu

Publications:

Moiemen NS, Vlachou E, Staiano JJ, Thawy Y, Frame JD. Reconstructive surgery with Integra dermal regeneration template: histologic study, clinical evaluation, and current practice. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):160S-174S.

Wood FM, Giles N, Stevenson A, Rea S, Fear M. Characterisation of the cell suspension harvested from the dermal epidermal junction using a ReCell® kit. Burns. 2012 Feb;38(1):44-51. doi: 10.1016/j.burns.2011.03.001. Epub 2011 Nov 12.

Waaijman T, Breetveld M, Ulrich M, Middelkoop E, Scheper RJ, Gibbs S. Use of a collagen-elastin matrix as transport carrier system to transfer proliferating epidermal cells to human dermis in vitro. Cell Transplant. 2010;19(10):1339-48. doi: 10.3727/096368910X507196. Epub 2010 Jun 3.

Wood FM, Stoner ML, Fowler BV, Fear MW. The use of a non-cultured autologous cell suspension and Integra dermal regeneration template to repair full-thickness skin wounds in a porcine model: a one-step process. Burns. 2007 Sep;33(6):693-700. Epub 2007 May 7.

• Responsible Party: Leon Nesti, Walter Reed National Military Medical Center
• ClinicalTrials.gov Identifier: NCT02469168
• Other Study ID Numbers: WRNNMC 391911-5
• First Submitted: June 3, 2015
• First Posted: June 11, 2015
• Results First Submitted: March 9, 2018
• Results First Posted: April 3, 2018
• Last Update Posted: August 7, 2018