Single-Stage Integra Reconstruction in Burns

NCT03077087 | Terminated Results FDA Device

• 1 other identifier: A16-734
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Thermal Burn

Outcome Measures

Primary Outcomes (1)

• The Time to 95% Healing of the Single-stage Reconstructed Skin Graft

  95% healing determined as charted in Standard of Care follow up visits

  Up to 12 months

Secondary Outcomes (1)

• Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss

  Up to 12 months

Study Arms (1)

Single-stage Integra

EXPERIMENTAL

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)

Interventions

thin Integra® (125 cm2) DEVICE

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.

Also known as: Integra®

Single-stage Integra

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (9)

• 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.

  PMID: 3048216 BACKGROUND

• 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.

  PMID: 19864070 BACKGROUND

• 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.

  PMID: 17828040 BACKGROUND

• 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.

  PMID: 12352131 BACKGROUND

• 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.

  PMID: 24426936 BACKGROUND

• 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.

  PMID: 19254877 BACKGROUND

• 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.

  PMID: 26649312 BACKGROUND

• 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.

  PMID: 23963344 BACKGROUND

• 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.

  PMID: 22047827 BACKGROUND

Limitations and Caveats

Both subjects were withdrawn by the PI due to their disease state. While subjects were deemed eligible at time of screening and consent upon surgical procedure the patients were deemed too unstable or inappropriate for the study treatment. Patients were notified of this and no further study activities were completed.

Results Point of Contact

• Title: Joshua S Rosenzweig / Study Coordinator
• Organization: Regions Hospital

joshua.s.rosenzweig@healthpartners.com

651-254-3351

Study Officials

• William Mohr, MD

  Regions Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 10, 2017
• Study Start: April 10, 2017
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: March 14, 2023
• Results First Posted: March 14, 2023

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)