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

NCT01437852 | Completed Phase 1 Results DMC

• 2 other identifiers: STRATA2011WFUHS 40269
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Skin Wound; Burns; Trauma-related Wound

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Wound Closure of the Treatment Sites at Three Months

  Determination of complete wound closure of both treatment sites was evaluated at 3 months.

  3 months

• Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28

  The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.

  28 days

Study Arms (1)

StrataGraft skin tissue

EXPERIMENTAL

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

Biological: StrataGraft Skin Tissue

Interventions

StrataGraft Skin Tissue BIOLOGICAL

StrataGraft skin tissue

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratatech, a Mallinckrodt Company: lead

Study Sites (6)

Maricopa Integrated Health Systems, Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

University of Colorado Hospital Burn Center

Aurora, Colorado, 80045, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

UT-Southwestern Medical Center

Dallas, Texas, 75390-9158, United States

Location

U.S. Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234-6315, United States

Location

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Mary Lokuta
• Organization: Stratatech Corporation, a Mallinckrodt Company

mlokuta@stratatechcorp.com

608-441-8358

Study Officials

• Study Director

  Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 21, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 16, 2019
• Results First Posted: December 13, 2018

Record last verified: 2018-12

Locations

US (6)