Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 2:33 AM
Study NCT ID:
NCT06857708
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Sponsor:
Benjamin T. Miller
Organization:
Study Overview
Official Title:
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Necrotizing fasciitis (NF) is a type of soft tissue infection that is characterized by necrosis of the subcutaneous tissues and muscle fascia. Prompt diagnosis and surgical exploration are crucial in the management of these potentially fatal infections.1,2 For most patients, this requires an initial extensive, wide debridement with repeated inspection and debridement every 24-48 hours to remove all necrotic tissue.3 As a result, tissue reconstruction often necessitates flap surgery with autologous, split-thickness skin grafting (STSG) for sufficient coverage. The process during which the wound bed becomes ready for skin grafting can be lengthy, arduous, and often times costly. Post-discharge regimens may consist of pain management for daily dressing changes, nutritional supplements, multiple follow up visits in clinic and likely the involvement of a plastic and reconstructive surgeon.4 Therefore, strategies to promote the healing of these wounds may significantly improve the morbidity of this disease.
One such adjunct to the management of wounds is the use of mammalian-derived extracellular matrices (ECM). Multiple published case reports have demonstrated the safety and efficacy of ECM in the healing process of complex wounds.5-12 A randomized controlled trial was conducted in patients with chronic venous ulcers using an ECM derived from the submucosal layers of the porcine jejunum.8 Their findings demonstrated significant improvement in wound healing as compared to a standard-care group at 12 weeks of treatment (55% vs 34%, p = 0.196).
Cytal® and MicroMatrix® (Integra LifeSciences, Plainsboro Township, NJ, U.S.A.) are acellular, ECM products derived from porcine bladder epithelial basement membrane and tunica propria. It is thought that these products provide an optimal environment for healing by providing a scaffold for tissue regeneration and promoting neovascularization. These products have previously been demonstrated to improve healing in NF wounds.9-12 However, to date, there have been no randomized controlled trials evaluating the efficacy of ECM in the healing of NF wounds. We hypothesize that wound beds treated with Cytal® and MicroMatrix® will have a significantly decreased time to skin graft readiness as compared to those treated with standard of care wound management.
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.
One such adjunct to the management of wounds is the use of mammalian-derived extracellular matrices (ECM). Multiple published case reports have demonstrated the safety and efficacy of ECM in the healing process of complex wounds.5-12 A randomized controlled trial was conducted in patients with chronic venous ulcers using an ECM derived from the submucosal layers of the porcine jejunum.8 Their findings demonstrated significant improvement in wound healing as compared to a standard-care group at 12 weeks of treatment (55% vs 34%, p = 0.196).
Cytal® and MicroMatrix® (Integra LifeSciences, Plainsboro Township, NJ, U.S.A.) are acellular, ECM products derived from porcine bladder epithelial basement membrane and tunica propria. It is thought that these products provide an optimal environment for healing by providing a scaffold for tissue regeneration and promoting neovascularization. These products have previously been demonstrated to improve healing in NF wounds.9-12 However, to date, there have been no randomized controlled trials evaluating the efficacy of ECM in the healing of NF wounds. We hypothesize that wound beds treated with Cytal® and MicroMatrix® will have a significantly decreased time to skin graft readiness as compared to those treated with standard of care wound management.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: