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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437852
• Other study ID #: STRATA2011
• Secondary ID: WFUHS 40269
• Status: Completed
• Phase: Phase 1
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2018
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Skin Wound
• Trauma-related Wound
• Wounds and Injuries

Intervention

Biological:
• StrataGraft Skin Tissue

Locations

Country	Name	City	State
United States	University of Colorado Hospital Burn Center	Aurora	Colorado
United States	UT-Southwestern Medical Center	Dallas	Texas
United States	U.S. Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	Maricopa Integrated Health Systems, Arizona Burn Center	Phoenix	Arizona
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Stratatech, a Mallinckrodt Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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