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

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: Colorectal Cancer; Surgical Site Infection; Complications; Chlorhexidine
• Intervention / Treatment: Procedure: Intraoperative area irrigation

• Study Type: Interventional
• Enrollment (Estimated): 532
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Nanchong, Sichuan, China, 637000
      • Recruiting
      • Nanchong Central Hospital
      • Contact: Yunhong Tian; Phone Number: PHD 13508087719; Email: drtianyunhong@126.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

8

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	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	Including anastomotic fistula, anastomotic hemorrhage, intestinal obstruction, deep vein thrombosis and so on	30 days

Collaborators and Investigators

• Sponsor: Nanchong Central Hospital

Study record dates

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: 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: 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