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NCT Number: NCT01782573

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

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.

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Key information

Conditions

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

Age range

18 year–92 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changhua Christian Hospital

Changhua, 500, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Antigerm, Hibiscrub

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

Other names: normal saline

Primary outcomes

  1. the positive rate of the baseline culture , the preoperative culture , and the postoperative culture

    Time frame: 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 outcomes

  1. the post - operative surgical site infection

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 4, 2013
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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