Comparison of Method for Skin Closure in Colorectal Cancer.

Yoon Suk Lee

Status: Invitation-only

Conditions: Surgical Site Infection; Colorectal Cancer

Treatments: Device: skin bond; Device: skin stapler

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06549803

KC21EISI0608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• underwent elective colorectal surgery
• aged 19 to 80 years
• ASA (American Society of Anesthesiologists) score: 1, 2
• surgical approach such as laparoscopic or Robotic Xi platform

Exclusion criteria

• ASA score above 3
• Aged over 80 years
• underwent combined surgery for other organ resection
• uncontrolled DM

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups

Skin adhesive bond

Experimental group

Description:

a group which skin closure was performed using Leukosan Adhesive skin bond

Treatment:

Device: skin bond

skin stapler

Active Comparator group

Description:

a group which skin closure was performed using skin stapler

Treatment:

Device: skin stapler