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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469168
Recruitment Status : Terminated (lack of funding)
First Posted : June 11, 2015
Results First Posted : April 3, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Leon Nesti, Walter Reed National Military Medical Center

Tracking Information
First Submitted Date  ICMJE June 3, 2015
First Posted Date  ICMJE June 11, 2015
Results First Submitted Date  ICMJE March 9, 2018
Results First Posted Date  ICMJE April 3, 2018
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Number of Participants With Adverse Event [ Time Frame: Prior to or at 12 weeks ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
Adverse Event [ Time Frame: Prior to or at 12 weeks ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Number of Participants With Confirmed Treatment Area Closure [ Time Frame: Prior to or at 6 weeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • Confirmed Treatment Area Closure [ Time Frame: Prior to or at 6 weeks ]
    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.
  • POSAS [ Time Frame: At Week 24 ]
  • Patient Preference (between ReCell versus control) [ Time Frame: at Week 24 ]
  • Vancouver Scar Scale [ Time Frame: At Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix
Official Title  ICMJE Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Skin Cell Harvesting Device in Combination With Widened Meshed Autograft Applied Over Bilayered Wound Matrix
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.
Detailed Description

The goal of the study described herein is to determine the safety, tolerability, preliminary and long-term effectiveness of the use of the Recell device over a widened STSG mesh. It is hypothesized the ReCell cell suspension, in combination with INTEGRA™ MBWM, will improve upon the current standard of care. The potential for ReCell's promotion of healing in the interstices of the STSG mesh may close gaps that are potential points of failure during subsequent rehabilitation and return to physical activity. Within the current study, each participant will serve as his/her own control, allowing for comparison of ReCell treated (experimental) and non-ReCell treated (control) regions of the grafted wound. In the proposed study, each patient will serve as his/her own control. Due to the nature of the study, only patients whose wounds have been previously successfully treated with INTEGRA™ MBWM as part of their standard of care will qualify for participation.

Therefore, as part of enrollment eligibility criteria for this study, the identified study wound will first be treated with INTEGRA™ MBWM. The wound will then be allowed to heal for approximately two to four weeks, at which time a viable granulation layer will have developed thus allowing for next stage STSG grafting. The timing of the STSG application will be determined by clinician judgment based on the state of the granulation process, which varies between patients, but typically takes 2 to 4 weeks.

Approximately two to four weeks after INTEGRA™ MBWM treatment, the studied wound will be divided into a ReCell-treated area (over 1:5 meshed STSG) and a control area treated with 1:1.5 meshed STSG (no ReCell). In all cases, the ReCell region may be up to 320cm2 in size; the upper limit of application area for one ReCell kit, with a similarly sized control region. If the wound is larger than the combined ReCell and control regions (over 640cm2), the areas outside the study regions will be designated as non-study areas and treated according to standard of care. The same primary and secondary dressings will be used on ReCell-treated areas, control areas and donor sites. Once the study and control wounds are determined to have healed, standard local clinical practice will be followed.

Within-subject comparisons of the ReCell region and control region, in order to evaluate improvements associated with use of ReCell, a battery of measurements and evaluations will be made. These measurements are divided into three categories: safety and tolerability, preliminary effectiveness (acute healing process) and long-term effectiveness.

The safety of research participants is foremost. Therefore, efforts will be made to control risks to participants throughout the duration of their study participation. Wound healing time, donor site morbidity and histology will be assessed during an acute 6 week phase, with follow-up visits at Weeks 1, 2, 3, 4 and 6 post-treatment.

Subjects will continue in the study for long-term follow-up with clinic visits at Week 12 and 24 post-treatment. Healing of treated wound sites (A region and B region) and donor sites (STSG 1:5, STSG 1:1.5 and ReCell) will be assessed at each visit. Treated wounds will be considered healed when 95% or greater of the study area has re-epithelialized by Week 6 post-treatment. Donor sites will be considered healed when ≥95% of the donor site has re-epithelialized by Week 4 post-treatment. Aesthetic and functional outcomes of the treated areas will be assessed and documented. Subject satisfaction will also be assessed and documented at these two time points.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Wounds and Injury
Intervention  ICMJE
  • Device: Recell
    ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
  • Procedure: Control
    Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
Study Arms  ICMJE
  • Experimental: ReCell
    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
    Intervention: Device: Recell
  • Active Comparator: Control
    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
    Intervention: Procedure: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2018)
1
Original Actual Enrollment  ICMJE
 (submitted: June 8, 2015)
20
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • 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:

      1. Hematocrit ≤ 20%
      2. INR > 1.8 second
      3. Creatinine (serum) > 2.0 mg/dL
      4. Bilirubin Total (serum) within upper limit of normal (normal range 0.3-1.9 md/dL
      5. Liver function test (AST/ALT) greater than 2 times upper limit of normal as defined by the clinical laboratory defined normal ranges
      6. Albumin (serum) < 2.0 g/dL
      7. 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)
    • The subject has other concurrent conditions that in the opinion of the investigator may compromise safety or study objectives
    • The subject has a known hypersensitivity to Trypsin and/or Compound Sodium Lactate for Irrigation (Hartmann's) solution
    • The subject cannot be compliant with study procedures and that, in the investigator's opinion, would interfere with the study objectives
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02469168
Other Study ID Numbers  ICMJE WRNNMC 391911-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leon Nesti, Walter Reed National Military Medical Center
Study Sponsor  ICMJE Rubin, J. Peter, MD
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Leon J Nesti, PhD Walter Reed National Military Medical Center
PRS Account University of Pittsburgh
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP