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RecruitingNCT06869096Updated Mar 31, 2026

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

An interventional study of Intraoperative area irrigation in Colorectal Cancer, Surgical Site Infection and Chlorhexidine, sponsored by Nanchong Central Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Nanchong Central Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2024, registered Mar 2025).
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
532
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
  • Surgical Site Infection
  • Chlorhexidine
  • Complications
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 532 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Nanchong Central Hospital is the lead sponsor of 20 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
532 participants (estimated)

Study arms

  • 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

  • No intervention
    Diabetic rectal cancer patients, saline irrigation group
  • Experimental
    Diabetic colon cancer patients, chlorhexidine irrigation group

    Procedure: Intraoperative area irrigation

  • No intervention
    Diabetic colon cancer patients, saline irrigation group
  • Experimental
    Non-diabetic rectal cancer patients, chlorhexidine irrigation group

    Procedure: Intraoperative area irrigation

  • No intervention
    Non-diabetic rectal cancer patients, saline irrigation group
  • Experimental
    Non-diabetic colon cancer patients, chlorhexidine irrigation group

    Procedure: Intraoperative area irrigation

  • No intervention
    Non-diabetic colon cancer patients, saline irrigation group

Interventions

  • ProcedureIntraoperative 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.

06

What researchers measure

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.

    Time frame: 30 days

Secondary outcomes

  1. Number of participants with Postoperative complication within 30 days

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

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Nanchong Central Hospital
    Nanchong, Sichuan 637000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06869096
Lead sponsor
Nanchong Central Hospital
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
Jul 2, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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