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Single-Stage Integra Reconstruction in Burns (Integra)

Primary Purpose

Thermal Burn

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
thin Integra® (125 cm2)
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thermal Burn

Eligibility Criteria

18 Years - 125 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Regions Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-stage Integra

Arm 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

Outcomes

Primary Outcome Measures

The Time to 95% Healing of the Single-stage Reconstructed Skin Graft
95% healing determined as charted in Standard of Care follow up visits

Secondary Outcome Measures

Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss
Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft

Full Information

First Posted
February 27, 2017
Last Updated
February 16, 2023
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03077087
Brief Title
Single-Stage Integra Reconstruction in Burns
Acronym
Integra
Official Title
Single-Stage Integra Reconstruction in Burns
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to feasibility issues with completing the study procedure.
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
July 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thermal Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-stage Integra
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
thin Integra® (125 cm2)
Other Intervention Name(s)
Integra®
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Time to 95% Healing of the Single-stage Reconstructed Skin Graft
Description
95% healing determined as charted in Standard of Care follow up visits
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss
Description
Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
125 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Mohr, MD
Organizational Affiliation
Regions Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD
Citations:
PubMed Identifier
3048216
Citation
Heimbach D, Luterman A, Burke J, Cram A, Herndon D, Hunt J, Jordan M, McManus W, Solem L, Warden G, et al. Artificial dermis for major burns. A multi-center randomized clinical trial. Ann Surg. 1988 Sep;208(3):313-20. doi: 10.1097/00000658-198809000-00008.
Results Reference
background
PubMed Identifier
19864070
Citation
Nguyen DQ, Potokar TS, Price P. An objective long-term evaluation of Integra (a dermal skin substitute) and split thickness skin grafts, in acute burns and reconstructive surgery. Burns. 2010 Feb;36(1):23-8. doi: 10.1016/j.burns.2009.07.011. Epub 2009 Oct 27.
Results Reference
background
PubMed Identifier
17828040
Citation
Branski LK, Herndon DN, Pereira C, Mlcak RP, Celis MM, Lee JO, Sanford AP, Norbury WB, Zhang XJ, Jeschke MG. Longitudinal assessment of Integra in primary burn management: a randomized pediatric clinical trial. Crit Care Med. 2007 Nov;35(11):2615-23. doi: 10.1097/01.CCM.0000285991.36698.E2.
Results Reference
background
PubMed Identifier
12352131
Citation
Ryan CM, Schoenfeld DA, Malloy M, Schulz JT 3rd, Sheridan RL, Tompkins RG. Use of Integra artificial skin is associated with decreased length of stay for severely injured adult burn survivors. J Burn Care Rehabil. 2002 Sep-Oct;23(5):311-7. doi: 10.1097/00004630-200209000-00002.
Results Reference
background
PubMed Identifier
24426936
Citation
Jacoby SM, Bachoura A, Chen NC, Shin EK, Katolik LI. One-stage Integra coverage for fingertip injuries. Hand (N Y). 2013 Sep;8(3):291-5. doi: 10.1007/s11552-013-9513-x.
Results Reference
background
PubMed Identifier
19254877
Citation
Burd A, Wong PS. One-stage Integra reconstruction in head and neck defects. J Plast Reconstr Aesthet Surg. 2010 Mar;63(3):404-9. doi: 10.1016/j.bjps.2008.11.105. Epub 2009 Feb 28.
Results Reference
background
PubMed Identifier
26649312
Citation
De Angelis B, Gentile P, Tati E, Bottini DJ, Bocchini I, Orlandi F, Pepe G, Di Segni C, Cervelli G, Cervelli V. One-Stage Reconstruction of Scalp after Full-Thickness Oncologic Defects Using a Dermal Regeneration Template (Integra). Biomed Res Int. 2015;2015:698385. doi: 10.1155/2015/698385. Epub 2015 Nov 16.
Results Reference
background
PubMed Identifier
23963344
Citation
Demiri E, Papaconstantinou A, Dionyssiou D, Dionyssopoulos A, Kaidoglou K, Efstratiou I. Reconstruction of skin avulsion injuries of the upper extremity with integra((R)) dermal regeneration template and skin grafts in a single-stage procedure. Arch Orthop Trauma Surg. 2013 Nov;133(11):1521-6. doi: 10.1007/s00402-013-1834-2. Epub 2013 Aug 21.
Results Reference
background
PubMed Identifier
22047827
Citation
Kosutic D, Beasung E, Dempsey M, Ryan L, Fauzi Z, O'Sullyvan B, Orr D. Single-layer Integra for one-stage reconstruction of scalp defects with exposed bone following full-thickness burn injury: a novel technique. Burns. 2012 Feb;38(1):143-5. doi: 10.1016/j.burns.2011.08.019. Epub 2011 Nov 1. No abstract available.
Results Reference
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Single-Stage Integra Reconstruction in Burns

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