Cryopreserved Placental Membranes Containing Viable Cells Result in High Closure Rate of Nonhealing Upper and Lower Extremity Wounds of Non-Diabetic and Non-Venous Pathophysiology

Eric L. Johnson, MD; Molly Saunders, BS; Tanushree Thote, PhD; Alla Danilkovitch, PhD

Disclosures

Wounds. 2021;33(2):34-40. 

In This Article

Results

Patient Demographics and Wound Characteristics

Ninety-two patients with 104 wounds treated between January 2016 and May 2019 with vCPM plus SOC satisfied the eligibility criteria. Patient demographics and wound characteristics are presented in Table 1 and Table 2. Of the 92 patients treated with vCPM, 42 were male and 50 were female, and the average age was 60.1 years. Significant comorbidities included hypertension (32.6%), diabetes mellitus (18.5%), hyperlipidemia (16.3%), coronary artery disease (10.9%), venous insufficiency (6.5%), congestive heart failure (5.4%), and chronic obstructive pulmonary disease (3.3%). Sixty-seven of the 104 wounds (64.4%) were surgical, 17 were traumatic (16.3%), 10 were burns (9.6%), and 10 were considered other wounds, which consisted of chronic ulcers, pressure ulcers, necrotizing fasciitis, and a pilonidal cyst (9.6%). Sixty-four wounds were upper-extremity wounds (61.5%) and 40 were lower-extremity wounds (38.5%). The median wound size was 3.15 cm2 (range, 0.02 cm2–210 cm2) with a median duration of 1.50 months (range, 0.03–180 months). Of the 104 wounds analyzed, 16 wounds received only vCPM-amnion applications, 78 received vCPM-chorion applications, and 10 received a combination of both.

Clinical Outcomes

Eighty-seven of the 104 wounds (83.7%) achieved complete wound closure with vCPM application in a median time of 41 days and with 3 applications (Figure 1). Eighty-five percent of surgical wounds, 82% of traumatic wounds, 90% of burns, and 60% of other wounds achieved complete closure. Fifty-three of the 64 (82.8%) upper-extremity wounds and 34 of the 40 (85.0%) lower-extremity wounds achieved complete closure (Figure 2). Further, 15 of the 16 wounds (93.3%) that received vCPM-amnion, 64 of the 78 wounds (82.1%) that received vCPM-chorion, and 8 of the 10 wounds (80.0%) that received both products achieved complete wound closure (Figure 3). There were no statistically significant differences in closure rates between the upper and lower extremities, nor between graft types. Further, there were no AEs related to vCPM application.

Figure 1.

A graphical representation of clinical outcomes with cryopreserved placental membrane containing viable cells (vCPM) application plus standard of care for (A) the proportion of patients who achieved complete wound closure, (B) time to closure, and (C) number of applications. The bars show standard error. P values were determined using a X2 test and Kruskal-Wallis test for nonparametric samples for categorical and continuous variables, respectively. The P values show no statistically significant differences.

Figure 2.

A graphical comparison of clinical outcomes with cryopreserved placental membrane containing viable cells (vCPM) by extremity for (A) the proportion of patients who achieved complete wound closure, (B) time to closure, and (C) number of applications. The bars show standard error. P values ere determined using a X2 test and Kruskal-Wallis test for nonparametric samples for categorical and continuous variables, respectively. The P values show o statistically significant differences for wound closure and time to closure, but show a significant difference for vCPM applications.

Figure 3.

A graphical comparison of clinical outcomes with cryopreserved placental membrane containing viable cells (vCPM) by graft type for (A) the proportion of patients who achieved complete wound closure, (B) time to closure, and (C) number of applications. The bars show standard error. P values were determined using a X2 test and Kruskal-Wallis test for nonparametric samples for categorical and continuous variables, respectively. The P values show no statistically significant differences.

Forty-five of 94 wounds (48%; duration missing for 10 wounds) were treated within 1 month of onset. Of these, 40 wounds (89%) achieved complete closure in a median time of 43.5 days (range, 8.0–177 days). Forty-nine wounds had greater than 1-month duration, and of these, 38 achieved closure in an average of 36 days (range, 6.0–409 days). These results were not statistically significant (P = .77).

Seventeen of 104 wounds (16%) did not achieve complete wound closure. These wounds had a median baseline wound size of 5.85 cm2 (range, 0.2–210 cm2) and a median duration of 2 months (range, 0.35–180 months). With vCPM application, nonclosed wounds achieved a median PAR of 54.2, and 4 wounds increased in size.

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