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

Abstract and Introduction

Abstract

Introduction: Complex wounds with exposed bone, muscle, tendon, or hardware continue to be a therapeutic challenge for wound care providers. Wounds with exposed structures are more susceptible to infection, necrosis, and amputation. As such, rapid granulation to cover exposed deep tissue structures is essential for patient recovery.

Objective: In this prospective, pilot study, the authors evaluate the clinical outcomes of a cryopreserved umbilical tissue graft containing viable cells (vCUT) in the treatment of complex wounds.

Materials and Methods: Ten patients with 12 wounds each received 1 application of vCUT. Two patients did not complete the study and were removed from the per-protocol population. Data analyses were performed on the remaining 8 patients with 10 wounds. The average wound area was 16.5 cm2 with an average duration of 10 months. Post-application, patients were followed for an additional 4 weeks for granulation, closure, and safety outcomes.

Results: By the end of the study, 8 of 10 (80.0%) vCUT-treated wounds achieved 100% granulation, and 3 wounds (30.0%) went on to achieve complete closure. The median area reduction was 40.5% and the median volume reduction was 59.4%.

Conclusions: The results of this study suggest vCUT in conjunction with standard of care can be a viable treatment option for acute and chronic lower extremity complex wounds.

Introduction

Nonhealing wounds, defined as any wounds that are unable to proceed through the normal phases of wound healing in a timely manner, are reported to affect 6.5 million people in the United States.[1] Underlying conditions such as diabetes, venous insufficiency, and persistent pressure are among key contributing factors for the development of such wounds.[2] Nonhealing complex wounds, specifically with exposed bone, tendon, muscle, or hardware, prove to be an even greater clinical challenge to physicians. When left open for prolonged periods of time, exposed deep tissue structures are at an increased risk for infection and tissue necrosis, which leads to an increased risk of amputation.[3,4] In addition to the physical disabilities associated with amputations, this patient population tends to have a decreased quality of life and an increased mortality rate, with the 5-year rate reported to be between 40% and 70%.[1] As such, rapid granulation to cover exposed deep tissue structures and subsequent wound closure are critical for patient recovery.

The current treatment for nonhealing wounds includes aggressive debridement, especially in cases in which osteomyelitis is present, nutritional support for any underlying conditions, infection management, establishment of adequate circulation, and application of dressings to protect and cover the wound.[5] In cases where conservative wound management is not feasible, the next option is a surgical treatment approach utilizing a local or distant skin flap to cover the wound. Unfortunately, as often is the case of complex wounds, these surgical treatments are not feasible due to the severity of the wound and/or paucity of donor site.[6,7] Thus, alternative advanced therapies are employed when using flaps is not feasible or fail.

In recent years, skin substitutes have been increasingly utilized in the management of complex wounds. Examples of such products include a bilayered matrix wound dressing (BMWD), a cryopreserved split-thickness allograft, and a cryopreserved umbilical tissue containing viable cells (vCUT).[8–10] A vCUT allograft retains the extracellular matrix, growth factors, and endogenous neonatal cells, including stem cells of the native tissue, and is indicated for use as a wound cover for acute and chronic wounds.[11]

Previously, clinical outcomes utilizing vCUT have only been described in small, retrospective case studies and reports. In 2017, Brandeisky et al[12] reported the outcomes of vCUT in the treatment of Achilles tendon rupture open repairs. Four patients received 1 surgical application of vCUT to augment Achilles tendon repair. The outcomes were compared with 4 matched control patients. Patients who received vCUT reported less pain, had minimal scarring and edema, and were able to return to work faster without any complications.[12] In a case report describing the use of vCUT in the management of a chronic rectovaginal fistula,[13] a 60-year-old female presented with a chronic fistula that had previously failed multiple surgical repairs. Three months after the surgical fistula repair augmented with vCUT, the repair remained intact and the perineal wound had completely closed.[13] In 2018, a case report[14] described the outcomes of vCUT in the augmentation of vaginal cuff closure during laparoscopic hysterectomy in a 36-year-old female. Six weeks postop, the patient had no granulation tissue, serosanguinous fluid formation, bleeding, odor, or pain.[14] Lastly, McGinness et al[10] retrospectively analyzed 10 patients with complex wounds and gas gangrene who received 1 intraoperative vCUT application. All 10 patients achieved complete wound closure, with fewer complications and a shorter hospital stays, compared with historical control for inpatient management of gas gangrene.[10]

Although vCUT has demonstrated positive clinical outcomes in several surgical applications, all studies were retrospective in nature. Herein, the authors present the results of a single-center, prospective, pilot study of vCUT use in the treatment of acute and chronic complex wounds.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....