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

NCT ID: NCT00618839

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-04-30

Brief Summary

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

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.

Conditions

Third Degree Burn; Burns; Wound Infection; Degloving Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

StrataGraft : cadaver allograft

All patients enrolled received StrataGraft skin tissue and an intrapatient control area treated with cadaver allograft in a split-wound design

Group Type: EXPERIMENTAL

StrataGraft Skin Tissue

Intervention Type: BIOLOGICAL

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).

Cadaver allograft

Intervention Type: PROCEDURE

The standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted.

Interventions

StrataGraft Skin Tissue

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).

Intervention Type: BIOLOGICAL

Cadaver allograft

The standard of care for temporary coverage of full thickness skin defects is coverage with cadaver allograft until the wound can be autografted.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Stratatech, a Mallinckrodt Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Stratatech, Inc., a Mallinckrodt Pharmaceeuticals

Locations

Arizona Burn & Trauma Center

Phoenix, Arizona, United States

University of Wisconsin-Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

References

Schurr MJ, Foster KN, Centanni JM, Comer AR, Wicks A, Gibson AL, Thomas-Virnig CL, Schlosser SJ, Faucher LD, Lokuta MA, Allen-Hoffmann BL. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009 Mar;66(3):866-73; discussion 873-4. doi: 10.1097/TA.0b013e31819849d6.

Reference Type: RESULT

PMID: 19276766 (View on PubMed)

Centanni JM, Straseski JA, Wicks A, Hank JA, Rasmussen CA, Lokuta MA, Schurr MJ, Foster KN, Faucher LD, Caruso DM, Comer AR, Allen-Hoffmann BL. StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial. Ann Surg. 2011 Apr;253(4):672-83. doi: 10.1097/SLA.0b013e318210f3bd.

Reference Type: RESULT

PMID: 21475006 (View on PubMed)

Other Identifiers

R44AR047499

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STRATA2001

Identifier Type: -

Identifier Source: org_study_id