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

Discussion

The main objective of this retrospective, single-center study was to evaluate clinical outcomes of vCPM, a cryopreserved placental allograft, in the treatment of upper-extremity and lower-extremity wounds of nondiabetic and nonvenous pathophysiology. Currently, there are several advanced options often used in the treatment of nonhealing wounds. One such treatment is negative pressure wound therapy (NPWT), which has been shown to promote granulation tissue and tissue perfusion, as well as to decrease edema, bacterial colonization, and wound drainage.[14] Hyperbaric oxygen (HBO) therapy has also been used in the treatment of nonhealing wounds, often in conjunction with a flap or graft. It is hypothesized that HBO therapy increases oxygen supply to the wound area, which is essential for wound healing.[15] Additionally, split-thickness skin grafts (STSG) can provide permanent coverage for larger surface areas and can be meshed with variable expansion ratios. However, the success of STSGs relies on a well-vascularized wound bed with healthy granulation tissue.[16] Moreover, NPWT, HBO, and STSG treatments are typically reserved for larger and more complex wounds. More recently, skin substitutes have been used in the treatment of non-DFU and non-VLU wounds. Such products include a bilayered dermal regenerative therapy, fetal bovine dermis, and porcine intestinal submucosa.[17–19] Although the literature supports the use of these treatment modalities, overall, data from larger, well-designed randomized, controlled trials are limited. Further, most institutions do not have an established protocol for non-DFUs and non-VLUs, and physicians are choosing treatment based on personal preference.

Many patients with non-DFU and non-VLU wounds also have significant comorbidities that negatively affect wound healing. In the present study, 58 of 92 patients (63%) had a significant comorbidity and/or were a current smoker. Previously, vCPM has prospectively shown clinical benefits in the treatment of nonhealing wounds in patients with multiple comorbidities.[10,20–22] Because the mechanisms of wound healing and factors/comorbidities precluding wounds from closure are universal for wounds of various etiologies and locations, it was logical to select vCPM to be evaluated and analyzed in the treatment of non-DFU and non-VLU wounds. Here, 83.7% of wounds achieved complete closure in a median time of 41 days (mean, 76 days). These results are similar to those seen in smaller studies using vCPM in the treatment of non-DFU and non-VLU wounds.

In 2016, Johnson et al[23] reported outcomes of amnion and chorion vCPM applications in the treatment of various types of wounds. They showed a closure rate of 81.8% (9 of 11) for surgical wounds and 83.3% (10 of 12) for other types of wounds, which consisted of traumatic wounds, burns, pyoderma gangrenosum, and others.[23] In 2 case reports describing the management of full-thickness thermal burns, patients received weekly debridement and vCPM-amnion application along with occupational therapy. The first patient sustained a 55.4 cm2 thermal burn with exposed bone and tendon and the second patient sustained a 4.7 cm2 crush burn. Both patients achieved complete wound closure in an average of 63.5 days and 7.5 applications, and they regained full range of motion in the affected limb and the hand digit.[24] Typically, these patients would receive an STSG in the operating room. In these cases, the patients were able to avoid the OR and receive serial applications of vCPM in the outpatient setting. Anselmo et al[25] also evaluated weekly application of vCPM-amnion in the treatment of an arterial ulcer, a pressure ulcer, and a reoccurring pyoderma gangrenosum ulcer. The pressure and arterial ulcers achieved closure at 4 and 5 weeks, respectively. The pyoderma gangrenosum ulcer achieved a 64% reduction in size after 9 applications.[25] In a case report describing the use of vCPM-chorion in the treatment of a large necrotic nasal tip wound, the patient achieved aesthetic wound closure in 21 days with 2 vCPM applications.[26] Lastly, Golla et al[27] evaluated outcomes of vCPM-chorion for augmentation with surgical flap closure in 4 nonhealing pressure ulcers. All 4 patients achieved complete closure in an average of 7 weeks without recurrence at an average 12-month follow-up.[27] The above-referenced studies all demonstrate clinical benefits of vCPM application in the treatment of wounds of different etiologies and locations. These studies also suggest no differences in clinical outcomes between vCPM-amnion and vCPM-chorion.

Overall, there is a lack of sufficient clinical evidence for skin substitutes in the treatment of some of the most prevalent types of wounds. The present study suggests that vCPM can result in positive clinical outcomes for wounds of any location. Fifty-three of the 64 (82.8%) upper-extremity wounds and 34 of the 40 (85.0%) lower-extremity wounds achieved complete closure. This study also showed similar closure outcomes in patients treated with vCPM-amnion, vCPM-chorion, and their combination. Closure rates for wounds managed with vCPM-amnion, vCPM-chorion, or their combination were 93.3%, 82.1%, and 80.0%, respectively, suggesting clinical equivalence between amnion and chorion vCPMs.

The high closure rate reported in this study could potentially be explained by the fact that nearly half of the wounds received vCPM applications earlier in treatment. For DFUs and VLUs, advanced therapies such as vCPM are not indicated for use until the wound has failed at least 4 weeks of SOC. Forty-five of 94 wounds in the current study (48%) were treated within a month of onset. Of these, 40 wounds (88.9%) achieved complete closure by the end of the study in a median time of 43.5 days. Of wounds with greater than 1-month duration, 38 of 49 (77.5%) achieved complete closure in a median time of 36 days. The results here suggest that there could be clinical benefit to using vCPM early in patient care. This is the same conclusion drawn from an expert wound-care panel, which suggested that early intervention with vCPM could contribute to efficient wound closure, especially in patients who are high-risk.[28]

This study reports outcomes for upper-extremity and lower-extremity wounds of nondiabetic and nonvenous pathophysiology. Results of this study demonstrate benefits of utilizing vCPM plus SOC for difficult-to-treat wounds. These data provide valuable insight for providers, hospitals, and payers as it relates to medically appropriate and necessary patient care for patients with nonhealing wounds.

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