NCT06549803

Comparison of Method for Skin Closure in Colorectal Cancer.

A Study on Comparison of Postoperative Outcome Between Conventional Skin Stapling and Tissue Adhesive (2-octyl Cyanoacrylate) for Skin Closure in Colorectal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Yoon Suk Lee · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Surgical Site Infection
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	skin bond	In the skin bond group, fascia closure is performed for incision sites of 10 mm or more, and skin bond is sufficiently applied after subcuticular suture. For incision sites less than 10 mm, subcuticular closure is performed without closing the fascia, and then skin bond is applied.
DEVICE	skin stapler	In the skin stapler group, fascia closure is performed on incision sites larger than 10 mm, and the skin is closed at 2-3 mm intervals using a stapler. For incision sites less than 10 mm, skin closure is performed using a skin stapler without closing the fascia.

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-08-12
• Last updated: 2026-04-09

Locations

1 site across 1 country: South Korea