StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

• Sponsor: Stratatech, a Mallinckrodt Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03005054
• Collaborator: (none)
• Enrollment: 3
• Locations: 4
• Arm: 1
• Actual Duration (Months): 23
• Patients Per Site: 0.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body.

This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss.

Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

Condition or Disease	Intervention/Treatment	Phase
Trauma-related Wound; Burns; Skin Wound	Biological: StrataGraft Skin Tissue; Procedure: Autograft	Phase 2

Detailed Description

The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: See detailed descriptionSee detailed description
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects
• Actual Study Start Date: Apr 24, 2017
• Actual Primary Completion Date: Mar 26, 2019
• Actual Study Completion Date: Mar 26, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: StrataGraft skin tissue

Biological: StrataGraft Skin Tissue; StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).; Procedure: Autograft; The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.

Outcome Measures

Primary Outcome Measures

1. Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months [3 months]

   The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.

2. Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months [3 months]

   Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage

Secondary Outcome Measures

1. Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months [within 3 months]

2. Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months [within 3, 6 and 12 months]

3. Percent Wound Closure at 3, 6, and 12 Months [within 3, 6, and 12 Months]

4. Cosmesis of Treatment Sites at 3, 6, and 12 Months [within 3, 6, and 12 Months]

   Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

5. Cosmesis of Donor Sites at 3, 6, and 12 Months [within 3, 6, and 12 Months]

   Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

6. Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28 [at days 3, 7, 14, 21, and 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Men and women aged 18-65 years, inclusive

2. Written informed consent

3. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting

4. Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting

• Total skin defect may consist of more than one wound area

1. Full-thickness complex skin defects requiring excision and autografting

2. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2

3. For thermal burns only, first excision and grafting of treatment sites

Exclusion Criteria:

1. Pregnant women and prisoners

2. Subjects receiving systemic immunosuppressive therapy

3. Subjects with a known history of malignancy

4. Preadmission insulin-dependent diabetic subjects

5. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives

6. Expected survival of less than three months

7. Participation in the treatment group of an interventional study within the 90 days prior to enrollment

8. Chronic wounds

9. The face, head, neck, hands, feet, buttocks, perineum, and area over joints

10. Treatment sites with exposed tendon or bony prominences

11. Chemical and electrical burns

12. Treatment sites adjacent to unexcised eschar

13. Clinical suspicion of infection at the anticipated treatment sites

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Burn Center	Phoenix	Arizona	United States	85008
2	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
3	U.S. Army Institute of Surgical Research Adult Burn Center	Fort Sam Houston	Texas	United States	78234-6315
4	University of Wisconsin Hospital	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Stratatech, a Mallinckrodt Company

Investigators

• Study Director: Study Director, Mallinckrodt

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 23, 2017

More Information

Publications

None provided.

• Responsible Party: Stratatech, a Mallinckrodt Company
• ClinicalTrials.gov Identifier: NCT03005054
• Other Study ID Numbers: STRATA2014; W81XWH-16-C-0202
• First Posted: Dec 29, 2016
• Last Update Posted: Aug 3, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stratatech, a Mallinckrodt Company: Full-thickness; Acute trauma
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Period Title: Overall Study
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Overall Participants	3
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	53
Sex: Female, Male (Count of Participants)
Female	3 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Not Hispanic or Latino	3 100%
Hispanic or Latino	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

Title	Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months
Description	The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	3
Participant 1	100
Participant 2	25
Participant 3	125

2. Primary Outcome

Title	Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months
Description	Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	3
Number [percentage of participants]	100 3333.3%

3. Secondary Outcome

Title	Percent of Subjects Requiring Autografting of the StrataGraft Treatment Site by 3 Months
Time Frame	within 3 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	0

4. Secondary Outcome

Title	Number of Participants With Complete Wound Closure of the Treatment Sites at 3, 6, and 12 Months
Time Frame	within 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	0

5. Secondary Outcome

Title	Percent Wound Closure at 3, 6, and 12 Months
Time Frame	within 3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	0

6. Secondary Outcome

Title	Cosmesis of Treatment Sites at 3, 6, and 12 Months
Description	Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Time Frame	within 3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	0

7. Secondary Outcome

Title	Cosmesis of Donor Sites at 3, 6, and 12 Months
Description	Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance
Time Frame	within 3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	0

8. Secondary Outcome

Title	Pain of Donor Sites Measured at Days 3, 7, 14, 21, and 28
Time Frame	at days 3, 7, 14, 21, and 28

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Measure Participants	0

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Arm/Group Title	StrataGraft Skin Tissue
Arm/Group Description	StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
All Cause Mortality
	StrataGraft Skin Tissue
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	StrataGraft Skin Tissue
	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)
Injury, poisoning and procedural complications
Graft complication	1/3 (33.3%)
Other (Not Including Serious) Adverse Events
	StrataGraft Skin Tissue
	Affected / at Risk (%)	# Events
Total	3/3 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	1/3 (33.3%)
Endocrine disorders
Hyperglycaemia	1/3 (33.3%)
Eye disorders
Cataract	1/3 (33.3%)
General disorders
Pain	1/3 (33.3%)
Infections and infestations
Fungal skin infection	1/3 (33.3%)
Pneumonia	1/3 (33.3%)
Injury, poisoning and procedural complications
Graft complication	2/3 (66.7%)
Psychiatric disorders
Anxiety	1/3 (33.3%)
Depression	1/3 (33.3%)
Skin and subcutaneous tissue disorders
Blister	1/3 (33.3%)
Excessive granulation tissue	1/3 (33.3%)

Limitations/Caveats

Due to protracted enrollment and limited wound closure in the first three subjects, the Sponsor decided to end further enrollment and the study was terminated with only 3 subjects enrolled into Cohort 1. No participants were enrolled into Cohort 2. Therefore, posted results include primary outcome measures for the 3 subjects enrolled, but no data for the secondary outcome measures.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.