Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2025-03-01
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Integra Cohort
Patient with a burn treated with Integra® in conjunction with standard of care (SOC)\* 12-36 months post final skin graft application. 25 unique cases will be enrolled into this group.
No interventions assigned to this group
BTM Cohort
Patient with a burn treated with BTM in conjunction with SOC\* 12-36 months post- skin graft application. 25 unique cases will be enrolled into this group.
No interventions assigned to this group
Combination Cohort
Patient with a burn treated with Integra and BTM in different regions of the body in conjunction with SOC\* 12-36 months post-skin graft application. Up to 10 unique cases can be enrolled into this group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patient had a deep dermal or full-thickness burn that required skin grafting that was first treated with Integra\* or BTM, and at least 70% 'take' followed by an autograft
3. Patient had final skin graft between 12-36 months prior enrollment in the study.
4. Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA.
5. Patient is ≥ 21 years of age at the time of treatment.
Exclusion Criteria
2. Patient was treated with Integra or BTM and closed via secondary intention.
3. Severe cognitive dysfunction or psychiatric disorders.
4. Immunocompromised patients.
21 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Yi Arnold
Role: STUDY_DIRECTOR
Medical Affairs
Other Identifiers
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T-IDRTTQ-001
Identifier Type: -
Identifier Source: org_study_id
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