Viable intact cryopreserved human placental membrane for a non-surgical approach to closure in complex wounds

Abstract

Objective: Advances in wound treatment have yielded successful approaches to complex wound closure through plastic surgery or other staged surgical methods. However, not all patients or wounds are candidates for such increasingly rigorous levels of interventions. The exploration of non-surgical treatment options that promote anatomical and functional tissue replacement on an outpatient basis without donor site morbidity is necessary to maximise opportunities for patient mobility and rehabilitation. The native components found in human placental membranes may offer alternative properties for the clinical management of these complex wounds.

Method: A 10-month, single-centre effectiveness review was conducted on the clinical outcomes in patients (n=12) treated with Grafix, a viable intact cryopreserved human placental membrane (vCPM), for complex wounds characterised by exposed bone, tendon, muscle, or hardware. Wounds were treated with routine standard of care in addition to weekly grafting with a vCPM.

Results: The average baseline wound area and duration at presentation were 17.5 cm2 and 11.2 weeks. All twelve cases resulted in granulation over the exposed structures followed by complete wound re-epithelialisation without the concomitant use of negative pressure wound therapy, hyperbaric oxygen therapy, or surgical intervention. The mean 4-week percentage area reduction was 62.5 %. The mean time to closure was 10 weeks with a mean graft use of 8.1 grafts. Of the wounds seven (58%) presented with exposed tendon associated with an actively moving joint, the functional integrity of which was maintained with a return to the previous range of motion upon wound closure.

Conclusion: These outcomes illustrate that vCPM is a clinically effective option in the non-surgical management of complex wounds in the outpatient setting, contributing to timely definitive closure without the risk of associated donor site morbidity.

Declaration of interest: Kazu Suzuki, DPM, CWS is a member of the Speakers' Bureau at Osiris Therapeutics Inc., Georgina Michael and Yeabsera Tamire belong to the Department of Medical Affairs at Osiris Therapeutics Inc.

Keywords: Grafix; complex wound; non-surgical; outpatient; placental membrane.