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Single-Stage Integra Reconstruction in Burns

NCT03077087 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-03-14

Study results available
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Summary

This is a prospective, descriptive, pilot case series involving patients with significant burns who are candidates for reconstruction with Integra®. Subjects would have a small area of the wound would, at the time of excision, have the smallest sheet of thin Integra® (125 cm2) placed and be immediately autografted with a 3:1 meshed split-thickness skin graft. Of note, 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area, so for even the smallest burns in our proposed trial, this area would represent a small portion of the patient's area of injury. The remaining injury areas would be covered with standard-thickness Integra® only.

Conditions

  • Thermal Burn

Interventions

DEVICE

thin Integra® (125 cm2)

125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion.

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • William Mohr, MD · Regions Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
125 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2019-07-24
Completion
2019-07-24
FDA Device
Yes

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 NCT03077087 on ClinicalTrials.gov