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

NCT06869096 | Recruiting

• 1 other identifier: 2024135
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Surgical Site Infection; Chlorhexidine; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with Postoperative complication within 30 days

  30 days

Study Arms (8)

Diabetic rectal cancer patients, chlorhexidine irrigation group

EXPERIMENTAL

After colorectal cancer surgery, flush the surgical area with chlorhexidine solution 1 minute before suturing the skin.

Procedure: Intraoperative area irrigation

Diabetic rectal cancer patients, saline irrigation group

NO INTERVENTION

Diabetic colon cancer patients, chlorhexidine irrigation group

EXPERIMENTAL

Procedure: Intraoperative area irrigation

Diabetic colon cancer patients, saline irrigation group

NO INTERVENTION

Non-diabetic rectal cancer patients, chlorhexidine irrigation group

EXPERIMENTAL

Procedure: Intraoperative area irrigation

Non-diabetic rectal cancer patients, saline irrigation group

NO INTERVENTION

Non-diabetic colon cancer patients, chlorhexidine irrigation group

EXPERIMENTAL

Procedure: Intraoperative area irrigation

Non-diabetic colon cancer patients, saline irrigation group

NO INTERVENTION

Interventions

Intraoperative area irrigation PROCEDURE

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.

Diabetic colon cancer patients, chlorhexidine irrigation group; Diabetic rectal cancer patients, chlorhexidine irrigation group; Non-diabetic colon cancer patients, chlorhexidine irrigation group; Non-diabetic rectal cancer patients, chlorhexidine irrigation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 11, 2025
• Study Start: July 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (1)