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The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone Iodine | Active Comparator | 7.5% povidone iodine soaping 10% povidone iodine painting |
|
| Chlorhexidine Gluconate | Active Comparator | 4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine | Drug | 7.5% povidone iodine soaping 10% povidone iodine painting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Surgical Site infection within 1month | Check the surgical site infection (SSI) rate within one month Superficial SSI, Deep SSI, Organ Site SSI decided by physician CDC Definition in 1999 Superficial incisional infection : involving only the skin or subcutaneous tissue of the incision Deep incisional Infection : involving the deep tissues (i.e. fascial and muscle layers) Organ Space Infection : involving any part of the anatomy (i.e. organ/space), other than the incision | within 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the infection source | If SSI occur, we check the infection source including types of bacteriae using culture. | within 1month |
| Number of patients with Drug Side effect. | We check the side effect of our drugs including chlorhexidine and povidione iodine. For example, itching sense, pruritis, ulticaria, redness, anaphylaxis |
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Inclusion Criteria:
Resection of following organs (clean-contaminated open surgery)
Aged 20 - 85 years old
Use Prophylactic antibiotics
Use Preoperative bowel preparation
Elective operation
ASA classification 1-2 ASA I : no known systemic disease ASA II : single systemic disease & mild or well controlled ASA III : multiple systemic diseases or moderately controlled systemic disease ASA IV : poorly controlled systemic diseases
adequate organ functions defined as indicated below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Sik Han, Ph.D. | Liver Cancer Center, National Cancer Center, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Republic of Korea | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27879993 | Derived | Park HM, Han SS, Lee EC, Lee SD, Yoon HM, Eom BW, Kim SH, Ryu KW, Park SJ, Kim YW, Park B. Randomized clinical trial of preoperative skin antisepsis with chlorhexidine gluconate or povidone-iodine. Br J Surg. 2017 Jan;104(2):e145-e150. doi: 10.1002/bjs.10395. Epub 2016 Nov 23. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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| Chlorhexidine gluconate | Drug | 4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting |
|
|
| Within 1 month |
| Number of patients with the postoperative sepsis induced by wound infection | Definition of Sepsis
| within 1 month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |