- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782573
The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients
The Efficacy of Pre - Disinfection Skin Scrub With 4% Chlorhexidine Gluconate in Preventing Surgical Site Infections for Patients With Hepatectomy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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
|
(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:
|
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
|
(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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the positive rate of the baseline culture , the preoperative culture , and the postoperative culture
Time Frame: within 30 days after the operation
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within 30 days after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 . |
within 30 days after the operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: YaoLi Chen, MD, Changhua Christian Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Postoperative Complications
- Digestive System Neoplasms
- Liver Diseases
- Wound Infection
- Infections
- Liver Neoplasms
- Surgical Wound Infection
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Dermatologic Agents
- Disinfectants
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- CCH - 110801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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