NCT03077087: Integra

Single-Stage Integra Reconstruction in Burns

Terminated NA Results posted Last updated 14 March 2023

What this trial tests

NA trial testing thin Integra® (125 cm2) in Thermal Burn in 2 participants. Terminated before completion.

Timeline

10 April 2017

Primary endpoint
24 July 2019

24 July 2019

Quick facts

Lead sponsor	HealthPartners Institute
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	10 April 2017
Primary completion	24 July 2019
Estimated completion	24 July 2019
Sites	1 location across United States

Drugs / interventions tested

• thin Integra® (125 cm2)

Conditions studied

• Thermal Burn — all drugs for Thermal Burn →

Sponsor

HealthPartners Institute

Who can join

Adults 18 to 125, any sex, with Thermal Burn. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were documented from the time of study enrollment (consenting) until the completion of study activities at 12 months (or until the patients were withdrawn from the study).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-stage Integra

Serious: 1/2 (50%)

Deaths: 0/2

Serious adverse events (1 terms)

Reaction	System	Single-stage Integra
Stroke	Vascular disorders	—

Most-reported serious reactions: Stroke.

Data from ClinicalTrials.gov NCT03077087 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advancements in Regenerative Strategies Through the Continuum of Burn Care.
   Stone Ii R, Natesan S, Kowalczewski CJ, Mangum LH, et al · · 2018 · cited 73× · PMID 30038569 · DOI 10.3389/fphar.2018.00672