Prospective, Single-Center, Open-Label, Pilot Study Using Cryopreserved Umbilical Tissue Containing Viable Cells in the Treatment of Complex Acute and Chronic Wounds

Robert F. Mullins, MD; Zaheed Hassan, MD; Bounthavy Homsombath, MD; Shawn Fagan, MD; Beretta Craft-Coffman, PA-C; Joan Wilson, MSN, MHA, RN; John G. Rumbaugh, MD; Molly Saunders, BS; Alla Danilkovitch, PhD

Disclosures

Wounds. 2020;32(8):221-227. 

In This Article

Materials and Methods

Study Population and Design

This was a prospective, single-center, open-label study evaluating vCUT in the treatment of acute and chronic complex wounds. Institutional review board (IRB) approval was obtained prior to patient enrollment at the Joseph M. Still Burn Center in Augusta, Georgia. All patients provided written informed consent before any study procedures were performed. The study was conducted in compliance with the principles outlined in the Declaration of Helsinki.

Between November 2018 and March 2019, 10 patients with 12 wounds were enrolled and received 1 application of vCUT. Patients were followed weekly for clinical and safety outcomes for an additional 4 weeks post-application. Patients 18 years or older with an acute or chronic complex wound between 5 cm2 and 80 cm2 were eligible for this study. Patients who had a hemoglobin A1c of more than 14% or an arterial ulcer were not eligible for this study, nor were non-compliant patients or those with drug or alcohol abuse.

Materials and Treatment Regimen

A vCUT allograft (Stravix; Osiris Therapeutics, Inc., a subsidiary of Smith+Nephew) is composed of umbilical amnion and Wharton's jelly and is indicated for use as a wound cover in the treatment of acute and chronic wounds without restriction to etiology or location. A vCUT allograft naturally conforms to complex anatomies and may be used over exposed bone, nerves, tendon, joint capsule, muscle, hardware, and surgical mesh. All vCUT allografts are processed aseptically in a controlled, clean environment, following rigorous quality assurance standards, and then stored and distributed for use in accordance with the regulations in 21 CFR 1271 and the standards of the American Association of Tissue Banks.

A vCUT graft is white to buff colored, about 1 mm to 3 mm in thickness, and packaged in a sterile polycarbonate jar contained within a heat-sealed pouch. To thaw, the jar is removed from the pouch and sterile saline is added directly to the jar. Once the product moves freely in the jar, it is ready for application. A vCUT graft can be stored between -75°C and -85°C and has a shelf life of 2 years.[12]

Prior to vCUT application, wounds were cleaned and debrided to remove dead and necrotic tissue. Patients then received either a 3 cm x 6 cm unit, a 2 cm x 4 cm unit, or a combination of multiple pieces in order to accommodate the size of the wound. Post-application, the wounds were dressed with a nonadherent dressing and secondary dressings when needed. The standard dressing used for patients was Mepitel (Mölnlycke Health Care) as the nonadherent dressing, with secondary dressings including Kerlix (Covidien) and ACE wraps (3M), though this varied slightly depending on the investigator's discretion. Patients returned weekly for an additional 4 weeks for ulcer and safety assessments.

Clinical Outcomes and Statistical Analyses

The primary endpoint of this study was proportion of patients who achieved 100% granulation. Secondary endpoints included time to granulation, percent decrease in wound area and volume, proportion of patients who achieved wound closure, and adverse events (AEs). Outcomes were evaluated using the per-protocol (PP) population.

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