Efficacy of the Application of a Purified Native Collagen With Embedded Antimicrobial Barrier Followed by a Placental Allograft on a Diverse Group of Nonhealing Wounds of Various Etiologies: A Case Series

George J. Koullias, MD, PhD


Wounds. 2021;33(1):20-27. 

In This Article

Materials and Methods

Sixteen patients (7 males, 9 females) with a mean age (standard deviation [SD]) of 75.5 years (7.6), with several comorbidities and wounds that did not respond to prior traditional treatments, were retrospectively included in the case series. As depicted in Table 1, patients presented to the clinic with upper and lower extremity wounds of various etiologies (venous leg ulcer [VLU] [n = 2], trauma [n = 4], postoperative [n = 5], diabetic foot ulcer [DFU] [n = 2], pressure ulcer [n = 1], and complicated insect bite [n = 2]), with a baseline wound mean area (SD) of 20.16 cm2 (21.84) and median area of 11.45 cm2. The mean (SD) and median duration were 5.17 months (8.51) and 3 months, respectively (Table 1). After a detailed explanation of the treatment plan, informed consent was obtained. Institutional review board approval was not deemed necessary. Thus, this is a single center case series without controls, and with possible allergy or ineligibility to any of the products used as the only exclusion criteria.

An entry arterial and venous examination was performed. Noninvasive arterial and venous insufficiency testing was completed for all patients with wounds and abnormal initial examinations. Any form of detected arterial insufficiency (as per the angiosome principle) thought to affect wound healing was corrected by either open or (more frequently) endovascular procedures. Similarly, any form of detected superficial venous insufficiency that was thought to result in ambulatory venous hypertension and that affected wound healing was addressed with endovenous or open techniques. These interventions were routinely performed in the first 2 to 3 weeks after initial patient evaluation. During these first 2 to 3 weeks, wounds were debrided weekly, followed by application of PCMP; after this initial period, weekly debridement was followed by application of placental allograft (HSAM or dACM) until healing was achieved. The change from using PCMP to using placental allografts was done if any of the following conditions was met: infection was controlled; drainage, periwound erythema, pain level, and inflammation were reduced; wound size was decreasing or improvement of wound healing ceased in the absence of infection; and granulation was present.

For all wounds, debridement involved routine use of local anesthetics and consisted of 2 different phases, the first in which surgical curettes were used and the second involving aggressive brushing of the wound with a 3% chlorohexidine surgical brush, followed by normal saline rinsing. The PCMP was applied unmoistened on the wound after debridement and then, to avoid migration from the wound, the PCMP was stabilized with an adhesive perforated dressing (Versatel; Medline Industries, Inc), after which a foam product was placed for drainage control. The same products used for stabilization and drainage control with PCMP after debridement were used for application of the placental allograft (HSAM or dACM). Adjunctive treatments, such as medicated or nonmedicated compression to manage deep venous insufficiency and offloading or limb compression with a pneumatic garment to manage coexisting lymphatic dysfunction, were administered at the discretion of the clinician.