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

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

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.

Study Overview

• Status: Completed
• Conditions: Burns; Wound Infection; Third Degree Burn; Degloving Injury
• Intervention / Treatment: Biological: StrataGraft Skin Tissue; Procedure: Cadaver allograft

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: StrataGraft : cadaver allograft; 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; 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).; Procedure: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Stratatech, a Mallinckrodt Company
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Study Director: Study Director, Stratatech, Inc., a Mallinckrodt Pharmaceeuticals

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Complex skin defects; Burns; Wound infection; Skin trauma
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Soft Tissue Injuries; Burns; Wound Infection; Degloving Injuries
• Other Study ID Numbers: STRATA2001; R44AR047499 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No