An Open Label Prospective Pilot Study to Evaluate the Efficacy of Cryopreserved Amniotic Tissue Grafts for Chronic Nonhealing Ulcers

作者：Chua Lorraine Siok May^*; O'Connell Julie; Kang Steven; Burks James; Jayanetti Chaminda; Pereda Juan Carlos; Reiss Ian

来源：Wounds, 2014, 26(5): E30-E38.

• amniotic membrane
• cryopreservation
• chronic ulcers
• wound healing
• venous ulcers

Purpose. To evaluate the efficacy of cryopreserved amniotic tissue (Neox Cord 1K Wound Matrix, Amniox Medical, Inc, Atlanta, GA) in treating chronic nonhealing leg ulcers. Material and Methods. Ten patients with chronic leg ulcers, 7 with venous stasis, and 3 that were idiopathic, were consecutively enrolled after being unresponsive to conventional therapies for at least 6 months. The amniotic tissue was applied on days 0, 3, 4, and 5, and at each weekly visit until week 7 when wound closure was < 50%. When wound reduction of > 50% was obtained, the amniotic tissue application was discontinued. At day 28, patients demonstrating no wound area reduction were discontinued and considered failed cases, while those who showed improvement continued follow up until complete healing or end of the 6-month study period. Results. Four cases were considered successful, as they reached 50% wound closure at day 4 through day 35; of these 4 cases, 3 cases demonstrated complete wound healing on day 10, day 49, and day 84, respectively. Four patients showed no wound area reduction while 2 patients were excluded because of wound infections unrelated to the graft. Conclusions. This pilot study suggests that cryopreserved amniotic tissue is safe, and may be considered as an alternative graft for treating chronic nonhealing leg ulcers of > 6 month's duration. Further investigation into the mechanism and potential application to diabetic foot ulcers is warranted.

• 出版日期2014-5