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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine gluconate ( CHG ) | Active Comparator | (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 |
|
| 0.9% Sodium Chloride ( N/S ) | Active Comparator | (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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the positive rate of the baseline culture , the preoperative culture , and the postoperative culture |
| within 30 days after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YaoLi Chen, MD | Changhua Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Changhua | 500 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20878942 | Background | 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. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| 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 |
|
|
| within 30 days after the operation |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |