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NCT Number: NCT06869096

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

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.

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Key information

Conditions

Colorectal Cancer Chlorhexidine Colonic Diseases Colorectal Neoplasms Complications 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 Site Infection Surgical Wound Infection Wound Infection

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Location status: Recruiting

Location contact

Yunhong Tian

CONTACT

[email protected]

PHD 13508087719

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 31, 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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