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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Surgical Site Infection
• Intervention / Treatment: Device: skin bond; Device: skin stapler

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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seocho
    • Seoul, Seocho, South Korea, 06591
      • Seoul St.Mary's hospital, the Catholic university of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin adhesive bond; a group which skin closure was performed using Leukosan Adhesive skin bond	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.
Active Comparator: skin stapler; a group which skin closure was performed using skin stapler	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of surgical site infection within 30 days after surgery	Comparative analysis of the frequency of surgical site infection up to 1 month after surgery in each group when tissue adhesive was applied and when skin stapling device was applied.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score	Post-operative pain score by VAS score were measured and compared with each other by understanding various factors through cost-effectiveness analysis, pain level, satisfaction, etc. after surgery between existing skin stapling and tissue adhesive for colon cancer patients.	through study completion, an average of 1 year
Postoperative wound dressing cost	Postoperative wound dressing cost between existing skin stapling and tissue adhesive for colon cancer patients.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Yoon Suk Lee
• Collaborators: Dalim BioTech Co., Ltd.
• Investigators: Study Chair: Yoon Suk Lee, M.D.,Ph.D, Department of Surgery, Seoul St.Mary's hospital

Publications and helpful links

General Publications

• Lee CS, Han SR, Kye BH, Bae JH, Koh W, Lee IK, Lee DS, Lee YS. Surgical skin adhesive bond is safe and feasible wound closure method to reduce surgical site infection following minimally invasive colorectal cancer surgery. Ann Surg Treat Res. 2020 Sep;99(3):146-152. doi: 10.4174/astr.2020.99.3.146. Epub 2020 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; skin adhesive bond; skin stapling
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Infections; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Wound Infection; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Surgical Wound Infection
• Other Study ID Numbers: KC21EISI0608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No