Chlorhexidine Gluconate Versus Saline for Flushing the Surgical Area During Colorectal Cancer Surgery

March 29, 2026 updated by: Nanchong Central Hospital

A Comparative Study of Chlorhexidine Versus Saline Irrigation of the Surgical Area During Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.

The aim of this study was to compare the effectiveness of chlorhexidine versus saline in flushing the surgical area during colorectal cancer surgery. The primary outcomes included surgical site infection, postoperative complication rates, et al.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

532

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Recruiting
        • Nanchong Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 18-85 years,
  2. Patients with surgically resectable colorectal tumors confirmed by CT/MRI before surgery
  3. All patients had a performance status score of 0 or 1 in the Eastern Tumor Cooperative group
  4. American Society of Anesthesiology grade I-III

Exclusion Criteria:

  1. The tumor may have distant metastasis
  2. History of previous abdominal surgery
  3. The patient has a history of other malignant tumors diagnosed in the past 5 years and has received radiotherapy and chemotherapy in the past
  4. There are obvious contraindications to surgery (obvious abnormal liver and kidney function, pregnancy)
  5. Participated in other clinical trials within the past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic rectal cancer patients, chlorhexidine irrigation group
After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin.
Procedure: Intraoperative area irrigation
After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin. According to abdominal cavity contamination, bleeding and tumor invasion to determine the flushing time and flush fluid volume. If the abdominal cavity infection is more serious or exudate more, the flushing time can be relatively prolonged. At last, there were no obvious blood residue, tissue fragments and suppurative secretions in abdominal cavity. Ensure that the surgical field of vision is clear, the surface of each organ is smooth, and there is no abnormal exudate.
No Intervention: Diabetic rectal cancer patients, saline irrigation group
Experimental: Diabetic colon cancer patients, chlorhexidine irrigation group
Procedure: Intraoperative area irrigation
After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin. According to abdominal cavity contamination, bleeding and tumor invasion to determine the flushing time and flush fluid volume. If the abdominal cavity infection is more serious or exudate more, the flushing time can be relatively prolonged. At last, there were no obvious blood residue, tissue fragments and suppurative secretions in abdominal cavity. Ensure that the surgical field of vision is clear, the surface of each organ is smooth, and there is no abnormal exudate.
No Intervention: Diabetic colon cancer patients, saline irrigation group
Experimental: Non-diabetic rectal cancer patients, chlorhexidine irrigation group
Procedure: Intraoperative area irrigation
After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin. According to abdominal cavity contamination, bleeding and tumor invasion to determine the flushing time and flush fluid volume. If the abdominal cavity infection is more serious or exudate more, the flushing time can be relatively prolonged. At last, there were no obvious blood residue, tissue fragments and suppurative secretions in abdominal cavity. Ensure that the surgical field of vision is clear, the surface of each organ is smooth, and there is no abnormal exudate.
No Intervention: Non-diabetic rectal cancer patients, saline irrigation group
Experimental: Non-diabetic colon cancer patients, chlorhexidine irrigation group
Procedure: Intraoperative area irrigation
After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin. According to abdominal cavity contamination, bleeding and tumor invasion to determine the flushing time and flush fluid volume. If the abdominal cavity infection is more serious or exudate more, the flushing time can be relatively prolonged. At last, there were no obvious blood residue, tissue fragments and suppurative secretions in abdominal cavity. Ensure that the surgical field of vision is clear, the surface of each organ is smooth, and there is no abnormal exudate.
No Intervention: Non-diabetic colon cancer patients, saline irrigation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Surgical site infection within 30 days
Time Frame: 30 days
Any surgical site infection within 30 days of surgery is classified as superficial incision, deep mouth, or organ space infection according to the U.S. Centers for Disease Control and Prevention standards.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Postoperative complication within 30 days
Time Frame: 30 days
Including anastomotic fistula, anastomotic hemorrhage, intestinal obstruction, deep vein thrombosis and so on
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanchong Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024135

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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