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

Sponsor

Changhua Christian Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01782573

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Tumors	Drug: Chlorhexidine gluconate Drug: 0.9% Sodium Chloride	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chlorhexidine gluconate ( CHG ) (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 (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 Other Names: Antigerm Hibiscrub
Active Comparator: 0.9% Sodium Chloride ( N/S ) (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 (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 Other Names: normal saline

Arm

Intervention/Treatment

Active Comparator: Chlorhexidine gluconate ( CHG )

(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

Other Names:

Antigerm

Hibiscrub

Active Comparator: 0.9% Sodium Chloride ( N/S )

(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

Other Names:

normal saline

Outcome Measures

Primary Outcome Measures

the positive rate of the baseline culture , the preoperative culture , and the postoperative culture [within 30 days after the operation]
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 .

Secondary Outcome Measures

the post - operative surgical site infection [within 30 days after the operation]
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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 92 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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