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

Changhua Christian Medical Foundation

Status and phase: Completed; Phase 4

Conditions: Liver Tumors

Treatments: Drug: 0.9% Sodium Chloride; Drug: Chlorhexidine gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT01782573

CCH - 110801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 92 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Chlorhexidine gluconate ( CHG )

Active Comparator group

Description:

(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

Treatment:

Drug: Chlorhexidine gluconate

0.9% Sodium Chloride ( N/S )

Active Comparator group

Description:

(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

Treatment:

Drug: 0.9% Sodium Chloride