Single-Stage Integra Reconstruction in Burns
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 125 |
| Updated: | 2/1/2019 |
| Start Date: | April 10, 2017 |
| End Date: | August 28, 2019 |
| Contact: | Sandi Wewerka, MPH |
| Email: | sandi.s.wewerka@healthpartners.com |
| Phone: | 651-254-5304 |
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.
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.
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.
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.
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.
We found this trial at
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Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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