The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients
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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 |
- 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 ]
- 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 .
- 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:
|
|
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 |
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
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 May 19, 2013