A quality improvement pilot assessment of the safety and associated outcomes of a viable cryopreserved umbilical tissue allograft as an adjunct surgical wrap in peroneus brevis tendon repair.

Surgical tendon repairs of the lower extremity are frequently associated with post-operative (post-op) risks that result in poor patient outcomes. Initially, increased pain levels may contribute to extended post-op rehabilitation while the development of tissue adhesions and fibrosis limit long-term functionality through reduced range of motion. Several surgical methods describing incorporation of various augmentative graft materials in tendon repair exist. However, reports demonstrating technique and both short- and long-term patient outcomes are lacking. Recently, advances in tissue preservation technology have led to the commercialization of human placental allografts. Of these available allogeneic biomaterials, the components found in human placental membranes may provide anti-inflammatory, antimicrobial, anti-adhesive, and antifibrotic properties to benefit surgical outcomes.Here, the authors introduce and technically describe the use of a viable cryopreserved umbilical tissue (vCUT) (Stravix, Osiris Therapeutics, Inc., Columbia, MD) as a complementary surgical wrap in primary tendon repair, with particular focus on the peroneus brevis. A pilot study was undertaken to assess the safety and potential for secondary rehabilitative outcomes associated with the use of vCUT in 5 tendon repair cases. The use of vCUT as a surgical tendon wrap was evaluated via the following primary endpoints at post-op day 7:Secondary investigative endpoints included clinical and rehabilitative outcome measures for comparative pain reduction and transition times to both controlled ankle movement (CAM) boot and normal shoe ambulation.All patients were followed for an average of 24.15 months (range 16.75-26.5 months) after surgery. For primary safety measures, erythema, tenderness, drainage, heat, and swelling was absent in all 5 surgical sites. None of the patients required post-op use of narcotics past day 7. The potential for long-term rehabilitative improvement with adjunct use of vCUT was also demonstrated through reduced pain and reduced transition times to functional and non-assisted ambulation in normal shoewear as compared to historical controls managed without vCUT.This surgical technique is simple and safe for patients and preliminary findings have demonstrated favorable clinical and rehabilitative outcomes over historically observed controls.

A case of Dupuytren's disease managed with viable cryopreserved placental membrane adjunct to open palmar fasciectomy.

Dupuytren's disease (DD) is a rare connective tissue disorder resulting in progressive fibrosis and thickening of the palmar fascia, and contracture of the fingers due to excessive collagen deposition. Staged surgical interventions are reserved for severe cases, yet worsening of fibrosis and contracture of fingers post-surgery, has been reported to have a recurrence rate as high as 85%. Here, the authors report on use of viable cryopreserved placental membrane (vCPM) allograft as an adjunct to open fasciectomy. In a patient with debilitating bilateral DD contractures of >20 years duration, this novel approach resulted in a 34.8% range of motion (ROM) improvement and ability to fully extend all digits of the right hand. No adverse events were recorded. At 1 year post-surgery, the patient has no decrease in ROM. Results indicate that vCPM incorporation in open fasciectomy may provide benefit in reducing contracture recurrence in DD patients.

Viable placental allograft as a biological dressing in the clinical management of full-thickness thermal occupational burns: Two case reports.

RATIONALE: Occupational burn injuries can be detrimental and difficult to manage. The majority of complex cases are referred and managed at regional burn centers where access to specialized care is available. As an alternative to hospitalization with staged surgical procedures, placental products may be used for outpatient medical management of these common burn injuries, especially if access to a regional burn center is limited or restricted.Fresh amnion has been a treatment of choice in burns for more than 100 years. As a biological covering with a broad scope of potential uses, human placental membranes represent a dressing that is particularly advantageous for burn therapy. Recent advances in tissue-preservation technology have allowed for the commercialization of placental amnion products. PATIENT CONCERNS: To address several complications associated with burn injuries-contractures, scar formation, and pain-a viable cryopreserved placental membrane (vCPM) (Grafix-PRIME, Osiris Therapeutics, Inc., MD) retaining the anti-inflammatory, anti-fibrotic, and antimicrobial properties of fresh placental tissues was chosen for clinical use in the 2 cases reported, where both patients had restricted access to the regional burn center. DIAGNOSES: Two cases of work-related extremity burns presented to a local rural hospital for immediate post-injury assessment. The 1 case was of a man who sustained a 55.4 cm full-thickness 3 degree thermal burn with exposed bone and tendon, to the left dorsal forefoot after having an industrial pressure washer caught on his work boot. The 2 case was of a female who sustained a 4.7 cm full-thickness 3 degree crush burn to the dorsum extensor surface of her dominant hand's index finger after applying 80-pounds per square inch of heated pressure from a hydraulic press. INTERVENTIONS: Both burn patients elected to continue their care at the outpatient-based wound and hyperbaric center, receiving a combination of weekly ad libitum debridement, applications of vCPM, and occupational therapy. OUTCOMES: Both burns reached timely wound closure, and patients regained full range of motion of the affected limb, allowing for early return to work. The average number of allograft applications was 7.5, allowing both patients to return to work in an average of 63.5 days without adverse events or post-treatment complications. LESSONS: The incorporation of this product in the treatment of these complex burns prevented amputation in one patient, and skin autografting and potential index finger contracture-formation in the second patient. The incorporation of vCPM in burn management may offer a new approach to outpatient burn management and may mitigate several of the complications seen post burn injury, leading to favorable patient outcomes.