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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2019-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01437852

Skin Wound Burns Trauma-related Wound

COMPLETED PHASE1

StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

NCT03005106

Burn, Thermal

COMPLETED PHASE3

StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects

NCT00618839

Third Degree Burn Burns Wound Infection +1 more

COMPLETED PHASE1/PHASE2

StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )

NCT04123548

Deep Partial-thickness Burn

COMPLETED PHASE3

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

NCT05517902

Skin Wound Burns Trauma-related Wound

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma-related Wound Burns Skin Wound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

See detailed description

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

StrataGraft skin tissue

Group Type EXPERIMENTAL

StrataGraft Skin Tissue

Intervention Type BIOLOGICAL

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

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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®).

Intervention Type BIOLOGICAL

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
5. Full-thickness complex skin defects requiring excision and autografting
6. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
7. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No