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 1st case was of a man who sustained a 55.4 cm2 full-thickness 3rd 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 2nd case was of a female who sustained a 4.7 cm2 full-thickness 3rd 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.

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 7:1. presence of erythema, tenderness, heat and/or swelling;2. pain score;3. patient use of narcotic medication; and4. the development of adverse events during any point during the post-op course, defined in this study as dehiscence, confirmed infection, fluid collection or drainage.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.

UV light can be used to irradiate platelets to reduce immune responses and activate chemically-mediated pathogen reduction agents. Platelets subjected to UV-based processing methods develop demonstrable losses of in vivo performance. We compared the “lesions” induced by the different wavelengths of UV light on human platelet performance in a SCID mouse animal model of recovery and survival. Previously we demonstrated that severe combined immunodeficient (SCID) mice could be used as an animal model to identify both severely damaged (Blood 106(11), p537a, 2005) and moderately damaged human platelets (Blood 108(11), p175–176a, 2006). Apheresis human platelets, stored for 1 or 7 days, were exposed to UVA(320–400 nm) or UVB(290–320 nm) light for 20 min (4.8 J/mL) or 40 min (9.6 J/mL). Control platelets were processed in the same manner without UV exposure. Effects on platelets were compared on platelet counts, activation measured by p-selectin (anti-human CD62P, clone AK-4) and in vivo recovery. Platelet counts and in vivo recovery are expressed as % of control platelets, p-selectin measurement represents % of cells expressing the antigen. For in vivo recovery, approximately 1×10 9 platelets (UV-treated or control) were injected into the tail vein of SCID mice (n=4 per each condition) and serial blood samples were collected. Human platelets were detected in mouse whole blood by flow cytometry using an anti-human GPIIbIIIa mAb (clone P2). Recovery was defined as percent of human platelets in mouse circulation 30 minutes post infusion. Comparison of recovery between control and UV treatment platelets was done at 2 hours post infusion as shown in Table 1. These results indicate that UVA produces less activation of platelets and less damage to human platelets recognized by the in vivo model than UVB. The UVA lesion detected by increased in vivo clearance is not cumulative in that longer exposures do not cause an increased loss of in vivo recovery. In comparison, UVB mediated damage is associated with lower in vivo recovery and the damage appears to be cumulative with longer exposure. These differences suggest that UVA and UVB exposure may produce platelet lesions through different mechanism(s). Further investigation into the molecular mechanisms of UVA and UVB lesions may lead to methods that could reduce the negative aspects of UV exposure. The findings and conclusions in this abstract have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy. Table 1 Treatment Day 1 Day 7 1= percent of control platelets;2=human platelet recovery in SCID mouse model Platelet count1 P-selectin (%) In vivo recovery2 Platelet count1 P-selectin (%) In vivo recovery2 UVA 20 min 100 13.3±2.7 55.2±7.6 100 20.3±3.8 58.2±4.9 40 min 100 9.9±0.9 55.5±2.9 100 17.3±2.9 54.3±6.7 UVB 20 min 82±3.7 34.6±5.0 30.8±8.9 86±5.3 51.1±6.4 18.5±4.6 40 min 51±10.1 29.5±1.5 6.9±2.6 63±10.5 36.2±1.8 2.47±0.9

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.