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Trial record 2 of 5 for:    stratagraft

StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

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ClinicalTrials.gov Identifier: NCT01437852
Recruitment Status : Completed
First Posted : September 21, 2011
Results First Posted : December 13, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Tracking Information
First Submitted Date  ICMJE September 19, 2011
First Posted Date  ICMJE September 21, 2011
Results First Submitted Date  ICMJE October 3, 2017
Results First Posted Date  ICMJE December 13, 2018
Last Update Posted Date October 16, 2019
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Number of Participants With Wound Closure of the Treatment Sites at Three Months [ Time Frame: 3 months ]
    Determination of complete wound closure of both treatment sites was evaluated at 3 months.
  • Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 [ Time Frame: 28 days ]
    The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
  • Wound closure of the treatment sites at three months [ Time Frame: 3 months ]
    Determination of complete wound closure of both treatment sites will be evaluated at three months.
  • Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 [ Time Frame: 28 days ]
    The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by day 28 will be determined.
Change History Complete list of historical versions of study NCT01437852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
Official Title  ICMJE An Open-Label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety and Efficacy of StrataGraft® Skin Tissue in Promoting the Healing of the Deep Partial-Thickness Component of Complex Skin Defects as an Alternative to Autografting
Brief Summary The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Wound
  • Burns
  • Trauma-related Wound
Intervention  ICMJE Biological: StrataGraft Skin Tissue
Study Arms  ICMJE Experimental: StrataGraft skin tissue

All subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio.

Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting

Intervention: Biological: StrataGraft Skin Tissue
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2013)
30
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2011)
20
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women aged 18-65 years, inclusive
  • Written informed consent
  • Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting
  • Complex skin defects of 3-49% TBSA requiring excision and autografting
  • Total burn may consist of more than one wound area
  • Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting
  • First excision and grafting of treatment sites

Exclusion Criteria:

  • Pregnant women and prisoners
  • Patients receiving systemic immunosuppressive therapy
  • Patients with a known history of malignancy
  • Preadmission insulin-dependent diabetic patients
  • Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
  • Expected survival of less than three months
  • Participation in the treatment group of an interventional study within preceding 90 days prior to enrollment
  • Full-thickness burns will be excluded as treatment sites
  • Chronic wounds will be excluded as treatment sites
  • The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites
  • Treatment sites adjacent to unexcised eschar
  • Clinical suspicion of burn wound infection at the anticipated treatment sites
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 NCT01437852
Other Study ID Numbers  ICMJE STRATA2011
WFUHS 40269 ( Other Grant/Funding Number: AFIRM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mallinckrodt ( Stratatech, a Mallinckrodt Company )
Study Sponsor  ICMJE Stratatech, a Mallinckrodt Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company
PRS Account Mallinckrodt
Verification Date December 2018

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