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Single-Stage Integra Reconstruction in Burns (Integra)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077087
Recruitment Status : Active, not recruiting
First Posted : March 10, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Thermal Burn Device: thin Integra® (125 cm2) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: William Mohr, MD Regions Hospital

Publications:

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03077087    
Other Study ID Numbers: A16-734
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries