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

Stratatech

Status and phase

Completed

Phase 2

Phase 1

Conditions

Third Degree Burn

Degloving Injury

Burns

Wound Infection

Treatments

Biological: StrataGraft Skin Tissue

Procedure: Cadaver allograft

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00618839

STRATA2001

R44AR047499 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This pilot Phase I/II clinical study will be conducted at up to three clinical sites.

This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.

Full description

Stratatech has completed a phase I/IIa clinical study to assess the safety and efficacy of escalating amounts of StrataGraft skin tissue in patients with complex skin defects requiring sequential debridement and temporary wound coverage with biological dressing prior to autografting. The specific objectives of this phase I/IIa clinical trial were to assess the safety of StrataGraft skin tissue using a predetermined panel of clinical and laboratory endpoints and assess the efficacy of StrataGraft skin tissue by comparing the ability of StrataGraft skin tissue to the standard of care, human cadaver skin, to condition complex skin defects for subsequent autografting. In three cohorts of five patients each, the maximum amount of StrataGraft skin tissue applied to excised full-thickness skin wounds was increased sequentially from 0.5% to 1.0%, and then to 1.5% TBSA. Equivalent study wound areas on each subject were treated with StrataGraft or cadaver allograft for one week, at which time the allograft tissues were removed and the wound bed was evaluated. Infection and appearance of the temporary allogeneic skin tissue were evaluated at every study session until autograft placement. The wound was covered with split-thickness skin autografts when the wound was judged ready to accept an autograft. Autograft take was assessed two weeks after autograft placement.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged greater than 18 yrs.
Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting
Full-thickness skin defects
Informed consent

Exclusion criteria

Prisoners
Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females
Immunosuppressive therapy
Infection with Human Immunodeficiency Virus
Venous stasis ulcers of the lower leg
Diabetic foot ulcers
Donor site wounds
Wounds of less than 5% body surface area
Wounds of the hands, face, and feet (although such wound surface areas can be counted toward total injured BSA)
Prior entry into this study
Expected survival of less than 3 months
Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, other serious or unstabilized organ damage from trauma, etc.)
Use of an investigational agent within 30 days
Active malignancy
Clinical evidence of malnutrition
Clinically significant renal, hepatic, cardiac, pulmonary, or neurological impairments