Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

The proposed registration study is designed as a phase III open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns. The proposed study will include patients with 3-49% total body surface area (TBSA) complex skin defects due to thermal burns with intact dermal elements for which excision and autografting are clinically indicated. The study has been designed to focus on the evaluation of efficacy and safety of StrataGraft skin tissue, while also assessing the potential for StrataGraft skin tissue to promote healing of complex skin defects due to thermal burns as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is approximately 70 subjects with complex skin defects caused by thermal burns that containing intact dermal elements and for which surgical excision and autografts are clinically indicated.

Official Title

A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated

Keywords

Trauma-related Wound Burns Skin Wound Wounds and Injuries StrataGraft Skin Tissue Autograft

Eligibility

You can join if…

Open to people ages 18 years and up

Subject-specific criteria:

  1. Men and women aged ≥ 18 years
  2. Written informed consent
  3. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
  4. Clinical expectation that the study donor site will heal without grafting
  5. Complex skin defects of 3-49% TBSA
  6. Total burn may consist of more than one area

Treatment site-specific criteria:

  1. Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
  2. Total of both study treatment areas can be up to 2000 cm2
  3. First excision and grafting of study treatment sites
  4. Thermal burn(s) on the torso, arms, or legs

You CAN'T join if...

Subject-specific criteria:

  1. Pregnant women
  2. Prisoners
  3. Subjects receiving systemic immunosuppressive therapy
  4. Subjects with a known history of malignancy
  5. Preadmission insulin-dependent diabetic subjects
  6. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
  7. Expected survival of less than three months
  8. Participation in the treatment group of an interventional study within 90 days prior to enrollment

Treatment site-specific criteria:

  1. Full-thickness burns
  2. . Chronic wounds
  3. . The face, head, neck, hands, feet, buttocks, and area over joints
  4. . Treatment sites immediately adjacent to unexcised eschar
  5. . Clinical or laboratory determination of infection at the anticipated treatment sites

Locations

  • Universtiy of California - Irvine Health Regional Burn Center
    Orange California 92868 United States
  • Arizona Burn Center at Maricopa Medical Center
    Phoenix Arizona 85008 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stratatech, a Mallinckrodt Company
ID
NCT03005106
Phase
Phase 3
Study Type
Interventional
Last Updated