Human Placental Connective Tissue Matrix in the Treatment of Chronic Wounds

A Prospective Multi-Center Case Series

 

Introduction

In recent recent years, application of amniotic membrane has expanded to the treatment of diabetic and venous stasis ulcers, postsurgica I wound dehiscence and chronic wounds. In this case series, we evaluated the efficacy of a Human Placental Connective Tissue Matrix Graft*.

Methods

This prospective, multicenter case series evaluated wound healing time and wound characteristics of fifteen patients with various etiologies. Up to two, six cm2 pieces of the Graft* were used per application on wounds ranging up to 44 cm2. The average number of applications was 2 with a max of 4. Length, width, and depth measurement as well as percent granulation tissue were measured at each weekly visit using a wound imaging camera. The wounds were cleaned and debrided based on the physician's discretion.

Screen Shot 2019-08-09 at 1.38.07 PM.png
Screen Shot 2019-08-09 at 1.38.14 PM.png

Results

All patients demonstrated a decrease in wound size and depth. There were no graft-related adverse events. The age of the ulcers ranged from 3 weeks to 4 years. There was also a notable decrease in would exudate and odor in all ulcers treated.

For the diabetic and venous ulcer cases:

  • The week 4 PAR (Percent Area Reduction) was 59%(71 % diabetic and 50% venous).
  • 62% (80% diabetic and 50% venous) of the cases had a week 4 PAR> than 40%.

For the diabetic and venous ulcer cases that started with a wound size less than 20 cm2 and where one six cm2 Graft* was used per application:

  • The week 4 PAR was 70% (82% diabetic and 62%venous).
  • 80% (100% diabetic and 67% venous) of the cases had a week 4 PAR> than 40%.

Conclusions

The Graft* was effective in reducing wound size and improving wound bed characteristics in chronic wounds.

Heather Connell CCRP1, Raphael Yaakov1, Keyur Patel DO2, Daniel DiMacro DO3, Lam Le MD4, Bryan Doner DO2, Laura Serena LPN1,2, Debbie Meyers LPN3, Lindsay Saunders4, Sharon McConnell CCRC1, Thomas Serena MD1

1SerenaGroup - Cambridge MA, 2The Wound Healing & HBO Center ACMH Hospital - Kittanning PA, 3The Wound Center St. Vincent Hospital - Erie PA, 4The Wound Center St. John's Health System - Tulsa OK