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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open-Label, Controlled, Randomized, Comparative, Dose Escalation Study Of The Safety, Human Immunology, And Efficacy Of StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects In Patients Undergoing Sequential Skin Reconstruction Procedures

Conditions
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Third Degree Burn, Burns, Wound Infection, Degloving Injury

Intervention / Treatment
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* Biological: StrataGraft Skin Tissue
* Procedure: Cadaver allograft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StrataGraft : cadaver allograft<br>All patients enrolled received StrataGraft skin tissue and an intrapatient control area treated with cadaver allograft in a split-wound design | Biological: StrataGraft Skin Tissue<br>* StrataGraft™ skin tissue is provided as a suturable circular patch of stratified epithelial tissue composed of a living dermal matrix (containing dermal fibroblasts) overlaid with human epidermal cells (NIKS™ cells).<br>Procedure: Cadaver allograft<br>* The standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue. | The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue. | two weeks post-autografting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of Allograft Tissues | The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points). | StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject. | 
| Viability of Allograft Tissues | Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells. | At the time of allograft removal ( 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin trauma, Complex skin defects, Burns, Wound infection