Single-Stage Integra Reconstruction in Burns

HealthPartners Institute

Status: Terminated

Conditions: Thermal Burn

Treatments: Device: thin Integra® (125 cm2)

Study type: Interventional

Funder types: Other

Identifiers

NCT03077087

A16-734

Details and patient eligibility

About

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.

Full description

Integra®, a synthetic dermal substitute, has been utilized in burn care for decades. Typically, 10-14 days after Integra® placement, a patient returns to the operating room, the top silastic layer of the Integra® is removed, and an autograft - a split-thickness skin graft harvested from the patient - is applied directly on top of the incorporated Integra®. The result is regarded to be a cosmetically and functionally superior result to that which would have been obtained had the wound bed itself been autografted at the time of excision, as opposed to being covered by Integra® and autografted during a second operation.

Integra® use in single-stage procedures to cover defects without grafting has shown benefit when defects are fairly small, e.g. fingertip injuries, and small head and neck skin cancer resections. While single-stage reconstruction with Integra® has been demonstrated with standard thickness Integra®, this decreased thickness would increase the likelihood of graft survival due to the decreased distance of nutrient diffusion.

Enrollment: 2 patients

Sex: All

Ages: 18 to 125 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English-speaking adult burn patients greater than 18 years old, admitted with burn injuries eligible for Integra® reconstruction at the discretion of the burn attending physicians.

Exclusion criteria

• patients with isolated hand or face burns - these burns are treated with sheet grafts (unmeshed); the 3:1 mesh grafts would not be used on these cosmetically sensitive areas. If they have hand and/or face burns in addition to other areas, they will not be excluded. However, the study itself will not be performed on the hands or face. Additionally, patients unable to present to our clinic for routine follow-up due to geographic limitations or otherwise will be ineligible.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Single-stage Integra

Experimental group

Description:

Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss

Treatment:

Device: thin Integra® (125 cm2)