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

Primary Purpose

Skin Wound, Burns, Trauma-related Wound

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

StrataGraft Skin Tissue

About this trial

This is an interventional treatment trial for Skin Wound

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maricopa Integrated Health Systems, Arizona Burn Center
University of Colorado Hospital Burn Center
Wake Forest University Baptist Medical Center
UT-Southwestern Medical Center
U.S. Army Institute of Surgical Research
University of Wisconsin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

StrataGraft skin tissue

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01437852

First Posted

September 19, 2011

Last Updated

October 11, 2019

Sponsor

Stratatech, a Mallinckrodt Company

1. Study Identification

Unique Protocol Identification Number

NCT01437852

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stratatech, a Mallinckrodt Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Wound, Burns, Trauma-related Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

StrataGraft skin tissue

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

StrataGraft Skin Tissue

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

3 months

Title

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

Description

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

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company

Official's Role

Study Director

Facility Information:

Facility Name

Maricopa Integrated Health Systems, Arizona Burn Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85008

Country

United States

Facility Name

University of Colorado Hospital Burn Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Wake Forest University Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

UT-Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9158

Country

United States

Facility Name

U.S. Army Institute of Surgical Research

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234-6315

Country

United States

Facility Name

University of Wisconsin Hospital

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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