Clinical trial NCT01782573: The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients
Official title: The Efficacy of Pre - Disinfection Skin Scrub With 4% Chlorhexidine Gluconate in Preventing Surgical Site Infections for Patients With Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Tumors
Keywords: pre - disinfection scrubbing solution
surgical site culture
surgical site infection
liver tumors
hepatectomy
chlorhexidine gluconate
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the positive rate of the baseline culture , the preoperative culture , and the postoperative culture
timeFrame: within 30 days after the operation
Secondary outcomes:
measure: the post - operative surgical site infection
timeFrame: within 30 days after the operation
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: YaoLi Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.