The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients

NCT01782573 | Completed Phase 4

• 1 other identifier: CCH - 110801
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more effective on the reduction of surgical site microbial colonization and subsequent infection than is normal saline.

Conditions

Liver Tumors

Keywords

pre - disinfection scrubbing solution; surgical site culture; surgical site infection; liver tumors; hepatectomy; chlorhexidine gluconate

Outcome Measures

Primary Outcomes (1)

• the positive rate of the baseline culture , the preoperative culture , and the postoperative culture

  1. Before surgical preparation while the patient was on the table in the operating room , we obtained the first set of aerobic culture from the predefined incision site as the baseline culture. 2. After skin scrubbing and disinfection , we obtained the second set of aerobic culture from the predefined incision site as the preoperative culture. 3. After closure of the wound , we obtained the third set of aerobic culture from the surgical site as the postoperative culture. 4. The result of culture was positive if bacteria were cultured from either stage of the surgical site sampling. 5. We compared the efficacy for eradicating aerobic bacterial pathogens ( reduction of positive culture )from the abdomen between the chlorhexidine gluconate scrubbing group and normal saline scrubbing group .

  within 30 days after the operation

Secondary Outcomes (1)

• the post - operative surgical site infection

  within 30 days after the operation

Study Arms (2)

Chlorhexidine gluconate ( CHG )

ACTIVE COMPARATOR

(i)a sterile washcloth was saturated with 60ml of chlorhexidine gluconate (4%) cleansing solution and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml

Drug: Chlorhexidine gluconate

0.9% Sodium Chloride ( N/S )

ACTIVE COMPARATOR

(i)a sterile washcloth was saturated with 60ml of sodium chloride (0.9%) and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml

Drug: 0.9% Sodium Chloride

Interventions

Chlorhexidine gluconate DRUG

(i)a sterile washcloth was saturated with 60ml of chlorhexidine gluconate (4%) cleansing solution and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml

Also known as: Antigerm, Hibiscrub

Chlorhexidine gluconate ( CHG )

0.9% Sodium Chloride DRUG

(i)a sterile washcloth was saturated with 60ml of sodium chloride (0.9%) and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml

Also known as: normal saline

0.9% Sodium Chloride ( N/S )

Eligibility Criteria

• Age: 18 Years - 92 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient who received elective hepatectomy for liver tumors

You may not qualify if:

• patients who were younger than 18 years of age
• patients who had a history of radiation to the operative sites
• patients who received repeat hepatectomy
• patients who had a history of allergy to CHG, ethyl alcohol or povidone - iodine
• patients whose tumors were metastatic cancers
• patients who had a preoperative active remote infection

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Changhua, 500, Taiwan

Location

Related Publications (1)

• Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214.

  PMID: 20878942 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Surgical Wound Infection

Interventions

chlorhexidine gluconate; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• YaoLi Chen, MD

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 4, 2013
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

TW (1)