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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chen Yao - Li, Changhua Christian Hospital
ClinicalTrials.gov Identifier:
NCT01782573
First received: January 29, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Liver Tumors
Drug: Chlorhexidine gluconate
Drug: 0.9% Sodium Chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Changhua Christian Hospital:

Primary Outcome Measures:
  • the positive rate of the baseline culture , the preoperative culture , and the postoperative culture [ Time Frame: within 30 days after the operation ] [ Designated as safety issue: Yes ]
    1. 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.
    2. After skin scrubbing and disinfection , we obtained the second set of aerobic culture from the predefined incision site as the preoperative culture.
    3. After closure of the wound , we obtained the third set of aerobic culture from the surgical site as the postoperative culture.
    4. The result of culture was positive if bacteria were cultured from either stage of the surgical site sampling.
    5. 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 [ Time Frame: within 30 days after the operation ] [ Designated as safety issue: Yes ]

    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 .



Enrollment: 100
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

Ages Eligible for Study:   18 Years to 92 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01782573

Locations
Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
Sponsors and Collaborators
Changhua Christian Hospital
Investigators
Principal Investigator: YaoLi Chen, MD Changhua Christian Hospital
  More Information

Publications:
Responsible Party: Chen Yao - Li, MD, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT01782573     History of Changes
Other Study ID Numbers: CCH - 110801
Study First Received: January 29, 2013
Last Updated: January 31, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Changhua Christian Hospital:
pre - disinfection scrubbing solution
surgical site culture
surgical site infection
liver tumors
hepatectomy
chlorhexidine gluconate

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Disinfectants
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 31, 2014