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.