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Evaluation Of CellerateRX® Utility In Reducing Groin Complications After Femoral Exposure
Vy C. Dang1, Charudatta S. Bavare, MD
2, Linda Le, MD
2, Trisha Roy, MD, PhD
2, Eric K. Peden, MD
2, Alan B. Lumsden, MD
2, Maham Rahimi, MD, PhD
2.
1Texas A&M University School of Medicine, Bryan, TX, USA,
2Houston Methodist Hospital, Houston, TX, USA.
OBJECTIVE: Vascular procedures involving groin incisions for femoral exposure often have complications that delay wound healing. These complications include but are not limited to development of seromas, hematomas, or infection requiring re-intervention leading to readmission, increased length of stay, and increased morbidity & mortality, including limb loss. An internal single-center retrospective review revealed a groin complication rate of 45.5%, suggesting an area for improvement. In this retrospective study, we evaluate the utility of CellerateRX® in preventing postoperative groin complications. We compare outcomes of groin incisions that received standard wound care and those that were additionally packed with CellerateRX® powder.
METHODS: Groin incisions required for femoral exposure in vascular surgery procedures were considered. Bilateral groin incisions account for two cases. The control group included cases between 2020-2021. The perioperative protocol in the management of these patients included one-hour preoperative vancomycin (15 mg/kg IV)/ceftriaxone (2 g IV), double skin preparation with 4% chlorhexidine, hair removal with surgical clippers, Ioban
TM, postoperative doxycycline (100 mg PO/IV BID), and negative pressure wound therapy/muscle flap/wound products in high-risk patients. Patients between 2021-2022 who met the described inclusion criteria were enrolled into the experimental group. The only change to the perioperative protocol of the experimental group was the addition of CellerateRX® powder to the surgical wound before closure. Patients were followed for 3-6 months for surveillance. The primary outcome was the number of groin complications that required return to the operating room (e.g., seroma, hematoma, infection).
RESULTS: The control group consisted of 116 groins, 19 (16.4%) of which developed complications—10 (8.6%) seromas, four (3.4%) hematomas, two (1.7%) soft tissue infections, and three (2.6%) skin necrosis cases. The treatment group consisted of 20 groins, 3 (15%) of which developed complications—two seromas and one soft tissue infection. A two-tailed Fisher’s exact test demonstrated no statistically significant association between the presence of complications and the treatment group (p-value = 0.67, 𝛼;;; = 0.05).
CONCLUSIONS: Based on the results of this study, we cannot conclude that packing wounds with CellerateRX® powder alters the risk of developing postoperative groin complications compared to standard wound care. Although the number of hematomas and skin necrosis were not observed in the treatment group, the observed difference may be due to the small sample size.
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