Comparison of Method for Skin Closure in Colorectal Cancer.

NCT06549803 | Completed

• 1 other identifier: KC21EISI0608
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infection; Colorectal Cancer

Keywords

colorectal cancer; skin adhesive bond; skin stapling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain score

  through study completion, an average of 1 year

• Postoperative wound dressing cost

  through study completion, an average of 1 year

Study Arms (2)

Skin adhesive bond

EXPERIMENTAL

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

Device: skin bond

skin stapler

ACTIVE COMPARATOR

a group which skin closure was performed using skin stapler

Device: skin stapler

Interventions

skin bond DEVICE

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.

Skin adhesive bond

skin stapler DEVICE

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.

skin stapler

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yoon Suk Lee: lead
• Dalim BioTech Co., Ltd.: collaborator

Study Sites (1)

Seoul St.Mary's hospital, the Catholic university of Korea

Seoul, Seocho, 06591, South Korea

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Surgical Wound Infection; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yoon Suk Lee, M.D.,Ph.D

  Department of Surgery, Seoul St.Mary's hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 12, 2024
• Study Start: March 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)