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A Study on Comparison of Postoperative Outcome Between Conventional Skin Stapling and Tissue Adhesive (2-octyl Cyanoacrylate) for Skin Closure in Colorectal Cancer
Compared to tissue adhesives and skin stapling devices, tissue adhesives are reported to have advantages in terms of wound infection and cost competitiveness. However, there have been no prospective randomized studies focusing on wound infection rates and cost competitiveness between skin stapling devices and tissue adhesives in colorectal cancer surgery. In colon cancer surgery, it is still unclear which skin suturing method has advantages such as lower postoperative wound infection rate and price competitiveness. The purpose of this study is to compare clinical outcomes, including wound infection rates and cost-effectiveness, between two different wound closure methods for colorectal cancer.
The primary purpose of the study is to compare and analyze the incidence of surgical site infection within 30 days after surgery in each group when tissue adhesive was applied and when skin stapling device was applied. The purpose of the secondary study is to compare the clinical results after surgery by analyzing cost-effectiveness, pain level, and satisfaction after surgery between existing skin stapling and tissue adhesive for colon cancer patients. Post-operative wound infection rate, cost (material costs of staplers, adhesives, material costs and service fees for disinfecting wounds occurring in the week after surgery), sex, age, BMI (body mass index), ASA (Anesthesiologists category), past history (diabetes, smoking history) , past abdominal surgery history), cancer stage, pre- and post-operative blood test results (WBC, CRP), biopsy results (cancer type), surgery time, pain on the 1st and 3rd days after surgery (VAS), length of stay, postoperative complications , compare the postoperative results of satisfaction.
Age
19 - 80 years
Sex
ALL
Healthy Volunteers
No
Seoul St.Mary's hospital, the Catholic university of Korea
Seoul, Seocho, South Korea
Start Date
March 1, 2022
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2025
Last Updated
February 24, 2025
304
ESTIMATED participants
skin bond
DEVICE
skin stapler
DEVICE
Lead Sponsor
Yoon Suk Lee
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
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