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

Primary Purpose

Liver Tumors

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Chlorhexidine gluconate
0.9% Sodium Chloride
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Tumors focused on measuring pre - disinfection scrubbing solution, surgical site culture, surgical site infection, liver tumors, hepatectomy, chlorhexidine gluconate

Eligibility Criteria

18 Years - 92 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Changhua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chlorhexidine gluconate ( CHG )

0.9% Sodium Chloride ( N/S )

Arm 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

(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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 29, 2013
Last Updated
January 31, 2013
Sponsor
Changhua Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01782573
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumors
Keywords
pre - disinfection scrubbing solution, surgical site culture, surgical site infection, liver tumors, hepatectomy, chlorhexidine gluconate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine gluconate ( CHG )
Arm Type
Active Comparator
Arm 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
Arm Title
0.9% Sodium Chloride ( N/S )
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Antigerm, Hibiscrub
Intervention 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
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride
Other Intervention Name(s)
normal saline
Intervention 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
Primary Outcome Measure Information:
Title
the positive rate of the baseline culture , the preoperative culture , and the postoperative culture
Description
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 .
Time Frame
within 30 days after the operation
Secondary Outcome Measure Information:
Title
the post - operative surgical site infection
Description
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 .
Time Frame
within 30 days after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YaoLi Chen, MD
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20878942
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.
Results Reference
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The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients

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