RECRUITING

The Management of Necrotizing Soft Tissue Infection Wounds with Cytal® Wound Matrix and MicroMatrix®

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

This is a prospective, pilot, parallel group, randomized controlled trial with 1:1 allocation. This will be a single center study coordinated at the Cleveland Clinic Foundation (CCF) Main Campus in Cleveland, Ohio. Data will be collected in a secure manner using REDCap housed at CCF. The study will consist of 2 arms: treatment with Cytal® Wound Matrix 2-Layer and MicroMatrix® (Integra LifeSciences, Plainsboro Township, NJ, U.S.A.) versus standard of care dressings. Wound debridement procedures will be performed by surgical staff at CCF. A co-investigator trained in the application of Cytal® Wound Matrix and MicroMatrix® will apply these treatments as outlined in section 6.1.2 Administration. This study will be conducted with IRB approval and written informed consent of each participant enrolled. The trial will be registered at ClinicalTrials.gov before the first participant is enrolled.

Official Title

The Management of Necrotizing Soft Tissue Infection Wounds with Cytal® Wound Matrix and MicroMatrix®

Quick Facts

Study Start:2025-03-05
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06857708

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults (≥ 18 years) with a diagnosis of necrotizing fasciitis
  2. 2. Wound ≥ 30 cm2
  3. 3. The participant is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
  1. 1. Burn as etiology of wound
  2. 2. Acute osteomyelitis requiring active treatment
  3. 3. Known allergy, hypersensitivity, or objection to porcine materials
  4. 4. Pregnant participants
  5. 5. Lack of English language fluency
  6. 6. Participant report of concurrent participation in another clinical trial that would interfere with this study
  7. 7. Inability to consent

Contacts and Locations

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Benjamin T. Miller

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 Date2025-03-05
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-03-05
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Necrotizing Fascitis
  • Necrotizing Soft Tissue Infection