Trial record 2 of 5 for:    stratatech

StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03005106
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Stratatech, a Mallinckrodt Company

Brief 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 up to 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.

Condition or disease Intervention/treatment Phase
Trauma-related Wound Burns Skin Wound Biological: StrataGraft Skin Tissue Procedure: Autograft Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: StrataGraft Skin Tissue Biological: StrataGraft Skin Tissue
StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).

Procedure: Autograft
The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.

Primary Outcome Measures :
  1. The difference in the percent area of the StrataGraft treatment site and control autograft treatment site that is autografted by 3 months [ Time Frame: 3 Months ]
  2. The proportion of subjects achieving durable wound closure of the StrataGraft treatment site at 3 months without autograft placement [ Time Frame: 3 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

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

    • Total burn may consist of more than one area

    Treatment site-specific criteria:

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

Exclusion Criteria

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:

  9. Full-thickness burns
  10. Chronic wounds
  11. The face, head, neck, hands, feet, buttocks, and area over joints
  12. Treatment sites immediately adjacent to unexcised eschar
  13. Clinical or laboratory determination of infection at the anticipated treatment sites

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03005106

Contact: Kristen Schaeve 800-556-3314

United States, Alabama
University of South Alabama Medical Center Recruiting
Mobile, Alabama, United States, 36617
United States, Arizona
Arizona Burn Center at Maricopa Medical Center Recruiting
Phoenix, Arizona, United States, 85008
United States, California
Universtiy of California - Irvine Health Regional Burn Center Recruiting
Orange, California, United States, 92868
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Health Shands Burn Center Recruiting
Gainesville, Florida, United States, 32610
Tampa General Hospital - Regional Burn Center Recruiting
Tampa, Florida, United States, 33606
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, Louisiana
Baton Rouge Medical Center Not yet recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Missouri
University of Missouri Not yet recruiting
Columbia, Missouri, United States, 65212
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Regional Medical Center Firefighters Burn Center Not yet recruiting
Memphis, Tennessee, United States, 38103
United States, Texas
U.S. Army Institute of Surgical Research Adult Burn Center Recruiting
Fort Sam Houston, Texas, United States, 78234-6315
United States, Wisconsin
University of Wisconsin Hospital Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Stratatech, a Mallinckrodt Company
Study Director: Matthew Barton Mallinckrodt

Responsible Party: Stratatech, a Mallinckrodt Company Identifier: NCT03005106     History of Changes
Other Study ID Numbers: STRATA2016
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries