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OpenTrials
Completed

NCT Number: NCT06549803

Comparison of Method 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.

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, Seocho, 06591, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. incidence of surgical site infection within 30 days after surgery

    Time frame: through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Postoperative pain score

    Time frame: through study completion, an average of 1 year

    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.

  2. Postoperative wound dressing cost

    Time frame: through study completion, an average of 1 year

    Postoperative wound dressing cost between existing skin stapling and tissue adhesive for colon cancer patients.

Sponsors and collaborators

Lead sponsor

Yoon Suk Lee

Other

Collaborators

  • Dalim BioTech Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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