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

NCT00618839 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-10-16

Study results available
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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

Interventions

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Stratatech, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Study Director · Stratatech, Inc., a Mallinckrodt Pharmaceeuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00618839 on ClinicalTrials.gov