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

NCT02469168 | Terminated Results DMC

• 1 other identifier: WRNNMC 391911-5
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to evaluate the safety, tolerability, preliminary and long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell) combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.

Conditions

Wounds and Injury

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Event

  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

  Prior to or at 12 weeks

Secondary Outcomes (1)

• Number of Participants With Confirmed Treatment Area Closure

  Prior to or at 6 weeks

Study Arms (2)

ReCell

EXPERIMENTAL

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

Device: Recell

Control

ACTIVE COMPARATOR

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

Procedure: Control

Interventions

Recell DEVICE

ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix

ReCell

Control PROCEDURE

Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a male or female military healthcare beneficiary of any race or ethnicity, aged 18 years or older, who is being treated for a traumatic wound at WRNMMC
• The subject has soft tissue loss resulting from a traumatic mechanism such as an explosive blast (i.e. motar, rocket, IED), high-velocity shells (i.e. missile), an avulsion injury, gunshot wound motor vehicle accident and/or burn secondary to blast
• The subject's full-thickness or deep partial-thickness traumatic wound injury has been treated with INTEGRA™ MBWM as part of their standard of care
• The wound area is at least 200 cm2
• All areas of the study wound area are covered with INTEGRA™ MBWM and has fully engrafted - engrafting defined as the presence of a contiguous vascularized granulation layer indicated by the formation of a viable granulation layer (Note: there may be some areas of incomplete granulation at the INTEGRA™ MBWM application site, these areas will be excluded from the study wound area).
• The subject will comply with protocol requirements
• The subject will provide voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

You may not qualify if:

• Subjects will not be eligible for study participation if they meet any of the following criteria:
• The subject is pregnant and/or lactating (self-reported)
• The subject has evidence of the following lab value results:
• Hematocrit ≤ 20%
• INR \> 1.8 second
• Creatinine (serum) \> 2.0 mg/dL
• Bilirubin Total (serum) within upper limit of normal (normal range 0.3-1.9 md/dL
• Liver function test (AST/ALT) greater than 2 times upper limit of normal as defined by the clinical laboratory defined normal ranges
• Albumin (serum) \< 2.0 g/dL
• Platelets \< 70 K/µL
• The subject's targeted traumatic wound injury is a craniofacial wound
• The subject's targeted traumatic wound injury is on a weight-bearing surface
• The subject's targeted traumatic wound is a full-thickness burn injury with visible eschar present (Note: Subjects with a traumatic wound of a burn nature secondary to an explosive blast injury resulting in significant soft tissue loss will NOT be excluded)
• The subject has active infection processes, that in the opinion of the investigator may compromise safety or study objectives
• The subject is known to have a pre-existing condition that may interfere with wound healing, e.g. malignancy, diabetes or autoimmune disease, immunocompromised blood borne diseases, has AIDS, is HIV or Hepatitis-A positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum)

Sponsors & Collaborators

• Rubin, J. Peter, MD: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (4)

• 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. doi: 10.1097/01.prs.0000222609.40461.68.

  PMID: 16799385 BACKGROUND

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

  PMID: 22079538 BACKGROUND

• 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.

  PMID: 20525428 BACKGROUND

• 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. doi: 10.1016/j.burns.2006.10.388. Epub 2007 May 7.

  PMID: 17485177 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Jody Richardson, MSN, RN
• Organization: Walter Reed National Military Medical Center

jody.richardson.ctr@usuhs.edu

301-295-7798

Study Officials

• Leon J Nesti, PhD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 11, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 7, 2018
• Results First Posted: April 3, 2018

Record last verified: 2018-07

Locations

US (1)