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

Nanchong Central Hospital

Status: Enrolling

Conditions: Surgical Site Infection; Chlorhexidine; Complications; Colorectal Cancer

Treatments: Procedure: Intraoperative area irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06869096

2024135

Details and patient eligibility

About

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.

Enrollment: 532 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

532 participants in 8 patient groups

Diabetic rectal cancer patients, chlorhexidine irrigation group

Experimental group

Description:

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

Treatment:

Procedure: Intraoperative area irrigation

Diabetic rectal cancer patients, saline irrigation group

No Intervention group

Diabetic colon cancer patients, chlorhexidine irrigation group

Experimental group

Treatment:

Procedure: Intraoperative area irrigation

Diabetic colon cancer patients, saline irrigation group

No Intervention group

Non-diabetic rectal cancer patients, chlorhexidine irrigation group

Experimental group

Treatment:

Procedure: Intraoperative area irrigation

Non-diabetic rectal cancer patients, saline irrigation group

No Intervention group

Non-diabetic colon cancer patients, chlorhexidine irrigation group

Experimental group

Treatment:

Procedure: Intraoperative area irrigation

Non-diabetic colon cancer patients, saline irrigation group

No Intervention group