Single-Stage Integra Reconstruction in Burns (Integra)
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|ClinicalTrials.gov Identifier: NCT03077087|
Recruitment Status : Active, not recruiting
First Posted : March 10, 2017
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thermal Burn||Device: thin Integra® (125 cm2)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Stage Integra Reconstruction in Burns|
|Actual Study Start Date :||April 10, 2017|
|Estimated Primary Completion Date :||November 28, 2019|
|Estimated Study Completion Date :||November 28, 2019|
Experimental: Single-stage Integra
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
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.
Other Name: Integra®
- The time to 95% healing of the single-stage reconstructed skin graft [ Time Frame: Up to 12 months ]95% healing determined as charted in Standard of Care follow up visits
- Frequency of complications: infection, seroma, hematoma, sloughing, and graft loss [ Time Frame: Up to 12 months ]Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077087
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55101|
|Principal Investigator:||William Mohr, MD||Regions Hospital|