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

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.

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Key information

Conditions

Skin Wound Burns Trauma-related Wound Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Maricopa Integrated Health Systems, Arizona Burn Center, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StrataGraft Skin Tissue

Biological

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Stratatech, a Mallinckrodt Company

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Sep 21, 2011
Registry last updated: Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed