Tissue Quality of Integra vs. BTM Treated Burns

Not yet recruiting

• Conditions: Burn Injury; Burn Scar; Burn Wounds - Partial Thickness (2nd Degree); Skin Grafting

• Registration Number: NCT06760611
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

An observational analysis of Integra-treated burns and Novosorb Biodegradable Temporizing Matrix (BTM)-treated burns will be undertaken 12-36 months post final skin graft application by retrospectively analyzing the patient's electronic medical record, and prospectively using a non-invasive measures of tissue quality and patient-reported outcomes. Patients will be offered the option to consent for a tissue biopsy for pathological evaluation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Study Start: 2026-03-01
• Primary Completion: 2026-10-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient has reviewed the IRB-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form.
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

1. Patient had a radiation burn.
2. Patient was treated with Integra or BTM and closed via secondary intention.
3. Severe cognitive dysfunction or psychiatric disorders.
4. Immunocompromised patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from Integra or BTM treated burns to autograft procedure	12-36 months post final skin graft application	The primary evaluation of clinical use of Integra- and BTM-treated burns will be undertaken by assessing the time from device application to autograft procedure (time to graft).
Vancouver Scar Scale assessment of tissue quality	12-36 months post final skin graft application	Tissue quality will be assessed using the Vancouver Scar Scale (VSS) (to qualitatively measure scar quality) between an overall score of 0-13.; A higher score on the VSS represents clinically worse scars.

Secondary Outcome Measures

Name	Time	Method
Percent of Integra or BTM 'take'	12-36 months post final skin graft application	Percent of Integra or BTM 'take' in burns treated with Integra vs burns treated with BTM
Length of Hospital Stays	12-36 months post final skin graft application	Length of hospital stay in days following treatment of burns with Integra or BTM
Number of complications	12-36 months post final skin graft application	Number complications (i.e. infection) in burns treated with Integra vs burns treated with BTM
Number of re-operations	12-36 months post final skin graft application	Number of re-operations in burns treated with Integra vs burns treated with BTM
Number of re-admissions	12-36 months post final skin graft application	Number of re-admissions in burns treated with Integra vs burns treated with BTM
Number of days in ICU	12-36 months post final skin graft application	Number of days in ICU of patients with burns treated with Integra vs burns treated with BTM
Time from admission to Integra or BTM application	12-36 months post final skin graft application	Time (number of days) from admission to Integra or BTM application to the burn
Autograft site details specifically associated with application of Integra or BTM on index injury	12-36 months post final skin graft application	Size, thickness, and mesh of autograft site specifically associated with application of Integra or BTM on index injury
Patient-Observer Scar Assessment Scale (POSAS)	12-36 months post final skin graft application	Qualitative evaluation of burns treated with Integra vs burns treated with BTM utilizing the POSAS.; The POSAS total score ranges from 6 to 60. The lower score corresponds to a situation of normal skin and as scores increase, it corresponds to a situation different from normal skin/
Patient Survey Question regarding neuropathic pain	12-36 months post final skin graft application	Patient survey question regarding neuropathic pain in burns treated with Integra vs burns treated with BTM.; Patient Survey Question: Do you experience neuropathic pain (numbness, pins and needles (tingling), or burning sensation) in your burn scar?
Tissue Pliability / Elasticity	12-36 months post final skin graft application	Use of a cutometer to measure tissue pliability / elasticity in burns treated with Integra vs burns treated with BTM.
Tissue Height	12-36 months post final skin graft application	Use of an ultrasound to measure tissue height in burns treated with Integra vs burns treated with BTM.
Tissue Density	12-36 months post final skin graft application	Use of an ultrasound to measure tissue density in burns treated with Integra vs burns treated with BTM.
Tissue Sensitivity	12-36 months post final skin graft application	Use of the Semmes-Weinstein Aesthesiometer to measure tissue sensitivity in burns treated with Integra vs burns treated with BTM.