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

NCT00618839 | Completed Phase 1 Results DMC

• 2 other identifiers: STRATA2001R44AR047499
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Third Degree Burn; Burns; Wound Infection; Degloving Injury

Keywords

Complex skin defects; Burns; Wound infection; Skin trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Appearance of Allograft Tissues

  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

  At the time of allograft removal (~7 days)

Study Arms (1)

StrataGraft : cadaver allograft

EXPERIMENTAL

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; Procedure: Cadaver allograft

Interventions

StrataGraft Skin Tissue 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).

StrataGraft : cadaver allograft

Cadaver allograft PROCEDURE

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

StrataGraft : cadaver allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratatech, a Mallinckrodt Company: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Arizona Burn & Trauma Center

Phoenix, Arizona, 85008, United States

Location

University of Wisconsin-Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 19276766 RESULT

• 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.

  PMID: 21475006 RESULT

MeSH Terms

Conditions

Burns; Wound Infection; Degloving Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections; Soft Tissue Injuries

Results Point of Contact

• Title: Mary Lokuta
• Organization: Stratatech Corporation

mlokuta@stratatechcorp.com

608-441-8358

Study Officials

• Study Director

  Stratatech, Inc., a Mallinckrodt Pharmaceeuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 20, 2008
• Study Start: July 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 16, 2019
• Results First Posted: September 10, 2012

Record last verified: 2018-12

Locations

US (2)