ACTIVE_NOT_RECRUITING

MicroMatrix® Flex in Tunneling Wounds

Conditions

Pressure Injury Venous Ulcer Necrotizing Soft Tissue Infection Diabetic Ulcers Draining Wound

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the safety and performance of MicroMatrix® Flex in subjects with wounds complicated by tunneling and/or undermining features.

Official Title

Prospective Evaluation of MicroMatrix® Flex in Wounds Complicated by Tunneling and Undermining

Quick Facts

Study Start:2024-12-12

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06629506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient is ≥ 22 years at the time of consent 2. Patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer, necrotizing soft tissue infection associated wound, dehiscing and/or draining wounds associated with open abdominal procedures, or any indication per the Instructions For Use 3. Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen 4. Patient has reviewed the IRB/IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB/IEC-approved consent form	1. Burn as etiology of wound 2. Unmanaged infection and/or osteomyelitis as determined pre-operatively 3. Known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other 4. Patient report of concurrent participation in another clinical trial that would interfere with this study 5. Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements

Inclusion Criteria

Exclusion Criteria

1. Patient is ≥ 22 years at the time of consent
2. Patient with a diagnosis of pressure injury, venous ulcer, diabetic ulcer, necrotizing soft tissue infection associated wound, dehiscing and/or draining wounds associated with open abdominal procedures, or any indication per the Instructions For Use
3. Patient is willing and able to adhere to protocol requirements and comply with the study follow-up regimen
4. Patient has reviewed the IRB/IEC-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB/IEC-approved consent form

1. Burn as etiology of wound
2. Unmanaged infection and/or osteomyelitis as determined pre-operatively
3. Known allergy, hypersensitivity, or objection to porcine materials, due to religion, culture, or other
4. Patient report of concurrent participation in another clinical trial that would interfere with this study
5. Any condition, concomitant medication, or concomitant treatment that, in the opinion of the investigator, would preclude the use of the study device or preclude the patient from completing the follow-up requirements

Contacts and Locations

Principal Investigator

Claire Witherel, Ph.D.

STUDY_DIRECTOR

Integra LifeSciences Corporation

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

MedStar Health Research Institute Inc.

Washington, District of Columbia, 20007

United States

Northwell Comprehensive Wound Healing Center

Lake Success, New York, 11042

United States

Collaborators and Investigators

Sponsor: Integra LifeSciences Corporation

Claire Witherel, Ph.D., STUDY_DIRECTOR, Integra LifeSciences Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Pressure Injury
Venous Ulcer
Necrotizing Soft Tissue Infection
Diabetic Ulcers
Draining Wound