Cisgender Cellular Tissue-Based Products Improve Wound Healing

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Wound closure rates vary amongst CTP types. Neither CTP sex effect of human female CTP¹ derived from cryopreserved placental membranes, nor male CTP² bioengineered from living human keratinocytes and foreskin fibroblasts has been described. Wound closure rates were reviewed in this study, by size over time, to establish the CTP sex's role in healing outcomes.

An IRB approved retrospective chart review of CTP cases (n = 216) at Northwell Health Comprehensive Wound Center from 2016-2020 was conducted. Variables included demographics, CTP type, wound type, and size. All subjects met a minimum institutional requirement of an ABI greater than 0.7. Outcomes of wound PC (included cases that reached <50% of initial size area [cm²] at any point in treatment), PC-End (when the final measurement area reached <50% of initial size), 50C, and CC rates at 1 and 3 months. Analysis included descriptive statistics, OR for PC and PC-End analysis, and chi-square for 50C and CC rates.

Male arterial and female VU were most common CTP recipients (Table 1) (chi square P = .03). Mean baseline size of VU was the largest in the cohort (VU, 42.4 cm²; arterial, 17.09 cm²; other, 9.26 cm²). For arterial ulcers, 9 males (16.6%) and 8 females (36.3%) underwent vascular intervention prior to application of CTP. The access to female CTP was limited for the entire cohort. Overall, cases with a CTP of the same sex more often showed 50 C (P = .03)  at 1 month. Male:male CTP application exhibited closure rates of 50C (P = .001) and CC (P < .01) at 3 months (Table 2). Cisgender CTP cases had PC (OR = 2.2) or PC-End (OR = 2.9) for all subjects (P < .01). Male:male PC and PC-End demonstrated better outcomes than female:female (OR = 1.8 both; P < .05). Best results occurred in male:male CTP with CC at 3 months (26%).

Overall outcomes were affected by sex, access, etiology, and follow-up. Sex CTP effect of female CTP and male CTP impact the recipient healing outcomes. Amniotic CTP literature has reported more male outcomes of varied etiologies³ (DFU reviews: 67%,⁴ 73%,⁵ and 84.6%⁶; mixed arterial VU and DFU etiology: 66.6%,⁷ 71.8 %,⁸ and 97.4%⁹). Additionally, both males and females were impacted by less access to female CTP (n = 21 and 25, respectively), but were similarly proportioned within respective sex groups. Examination of CTP outcome disparities showed that cisgender-treated CTP wounds achieved better closure. Additionally, better male PC, PC-End, and CC rates over time may be an effect of the compounded benefit of more male CTP availability and use. 

Healing or closure rates lack uniformity in the literature and can be area or time based (eg, time to heal^3,6 in days, 12-week or 16-week rate cut off,^4,10 or complete closure). Wound cross-section square area or percent changes^8,11 are also described; the current study reports both time and area (in PC and PC-End results). Uniform evaluation of both cross section area rates and consistent temporal reporting is necessary in wound closure studies. DFUs (whether neuropathic or not) were included in the arterial group for this study. Regardless of this, the venous group overall was disproportionally female (Table 1). 

Limitations included how etiology as an inclusion/exclusion criterion to define a study group can have overlapping diagnoses within an individual. Follow-up attrition affected both 1- and 3-month datasets (Table 2), and female CTP use was a smaller subset in the study.

Cisgender CTP wounds had better closure. Overall, male:male PC, PC-End, and CC rates over time were better. Healing outcome was affected by access, etiology, and follow-up.

Authors: Christina Del Pin, MD^1,2; Amit Rao, MD¹; Meaghan Coles, MS3¹; Manuel Beltran Del Rio, PhD³; and Alisha Oropallo, MD^1,2

Affiliations: ¹Northwell Health System, Department of Surgery, Comprehensive Wound Healing Center and Hyperbarics, North New Hyde Park, NY; ²Donald & Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY; ³Northwell Health, Department of Surgery, New Hyde Park, NY

Disclosure: Data published herein were presented at the Symposium on Advanced Wound Care Spring 2023 in poster format. The authors disclose no financial or other conflicts of interest.

Correspondence: Christina Del Pin, MD; Northwell Health Comprehensive Wound Healing Center and Hyperbarics, 1999 Marcus Avenue, Suite M6, Lake Success, NY 11042; cdelpin@northwell.edu

Manuscript Accepted: December 19, 2023