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

Liver Tumors Clinical Trial

Official title:

The Efficacy of Pre - Disinfection Skin Scrub With 4% Chlorhexidine Gluconate in Preventing Surgical Site Infections for Patients With Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782573
• Other study ID #: CCH - 110801
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2013
• Last updated: January 31, 2013
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Surgical site infections (SSIs) following elective surgical procedures occur most commonly as a result of colonization by the patient's native skin flora . The most common pathogens causing SSIs are Staphylococcus aureus and coagulase-negative Staphylococci , components of normal skin flora . Therefore, preoperative disinfection of the surgical site with an antiseptic skin preparation is standard practice before any surgical intervention to decrease skin microbial counts before incision . It is considered an important step in limiting surgical wound contamination and preventing infection.

A variety of skin-preparation agents and methods are available for preventing surgical site infections and the techniques for preoperative cleansing of the skin vary among hospitals and surgeons. There is a pressing need to elucidate the effect of cutaneous disinfection with chlorhexidine gluconate ( CHG ) in prevention of surgical site infections.

Many studies demonstrated that comparisons with cutaneous disinfection with povidone-iodine, disinfection with CHG before insertion of an intravascular device and for post-infection site care can substantially reduce the incidence of device-related infection .

Hence, this study aimed to test whether an additional chlorhexidine gluconate scrub followed by a routine disinfection would lower the incidence of surgical site culture and subsequent infection after hepatic resection. This data will show the originality and clinical importance of a cutaneous pre-disinfection scrubbing solution for such risk patients with hepatectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 92 Years

Eligibility

Inclusion Criteria:

• patient who received elective hepatectomy for liver tumors

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumors
• Surgical Wound Infection

Intervention

Drug:
• Chlorhexidine gluconate
(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
• 0.9% Sodium Chloride
(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

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the positive rate of the baseline culture , the preoperative culture , and the postoperative culture	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.; After skin scrubbing and disinfection , we obtained the second set of aerobic culture from the predefined incision site as the preoperative culture.; After closure of the wound , we obtained the third set of aerobic culture from the surgical site as the postoperative culture.; The result of culture was positive if bacteria were cultured from either stage of the surgical site sampling.; 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	Yes
Secondary	the post - operative surgical site infection	Surgical site infection was using modified US Centers for Disease Control and Prevention definitions for nosocomial infection and documented by visiting patients everyday during the duration of hospitalization after surgery . After discharge , patients were checked weekly in the outpatient clinic to assess the surgical sites infection . All surgical site infections were classified as superficial , deep wound , or organ / space infection .; We compared the incidence of post - operative surgical site infection between the chlorhexidine gluconate scrubbing group and normal saline scrubbing group .	within 30 days after the operation	Yes