StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects - Full Text View

Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00618839

Purpose

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.

Condition	Intervention	Phase
Skin Defects Burn Wounds Wounds From Infection Skin Trauma Wounds	Biological: StrataGraft Skin Tissue	Phase I Phase II

MedlinePlus related topics: Burns Injuries Surgery Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

To evaluate StrataGraft™ skin tissue as an alternative to allograft skin in the surgical management of complex skin defects. To evaluate the success of autograft take on wounds prepared by StrataGraft™ skin tissue. [ Time Frame: Percent autograft take is measured at two weeks post-autografting. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assessment of safety laboratory values at time of StrataGraft™ skin tissue removal and at three months as compared to baseline. [ Time Frame: One to two weeks post product application. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	July 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
StrataGraft: Experimental StrataGraft skin tissue	Biological: 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618839

Locations

United States, Arizona
Arizona Burn & Trauma Center
Phoenix, Arizona, United States, 85008
United States, Wisconsin
University of Wisconsin-Hospital and Clinics
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

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

Investigators

Study Director:

John M Centanni, MS

Stratatech

More Information

No publications provided

Responsible Party:	University of Wisconsin-Hospital and Clinics ( Michael J. Schurr, MD )
Study ID Numbers:	STRATA2001, R44 AR047499, NIAMS
Study First Received:	February 7, 2008
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00618839 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Complex skin defects of at least 5% Total Body Surface Area (TBSA) requiring sequential surgical procedures
Burn Wounds
Wounds from infection
Skin trauma wounds such as degloving injuries

Study placed in the following topic categories:

Burns
Wounds and Injuries

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on May 07, 2009