Surgical Site Infection
Conditions
Keywords
surgical site infection, chlorhexidine gluconate, povidone iodine
Brief summary
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.
Interventions
DRUGPovidone-Iodine
7.5% povidone iodine soaping 10% povidone iodine painting
DRUGChlorhexidine gluconate
4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
Sponsors
Seung Duk Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Resection of following organs (clean-contaminated open surgery) * Liver, Pancreas, Bile duct, Duodenum * Stomach * Colon, Small bowel 2. Aged 20 - 85 years old 3. Use Prophylactic antibiotics 4. Use Preoperative bowel preparation 5. Elective operation 6. 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 7. adequate organ functions defined as indicated below: * WBC 3000 \ 12 000/mm3 * \> Hb 8.0 g/dl * \> Plt 100 000/mm3 * \< Cr 1.2 mg/dl
Exclusion criteria
1. allergy to chlorhexidine or povidone 2. clean surgery or contaminated surgery 3. patients who cannot be followed up during 1 month 4. patients taking immunosuppressant drugs or chemotherapy agents 5. emergent surgery and reoperation 6. uncontrolled diabetes, BMI \> 30 kg/m2 7. vulnerable patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Surgical Site infection within 1month | within 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify the infection source | within 1month | If SSI occur, we check the infection source including types of bacteriae using culture. |
| Number of patients with Drug Side effect. | Within 1 month | We check the side effect of our drugs including chlorhexidine and povidione iodine. For example, itching sense, pruritis, ulticaria, redness, anaphylaxis |
| Number of patients with the postoperative sepsis induced by wound infection | within 1 month | Definition of Sepsis 1. Proven infection (by culture, stain) or a clinical syndrome pathognomonic for infection (WBC, imaging finding or petechiae, purpura, or purpura fulminans) 2. Body temperature (\<36 or \>38 Celsus Degree) 3. Heart rate \> 90 beats per minute 4. Respiratory rate \> 20 breaths per minute or, on blood gas, a PaCO2 less than 32 mmHg 5. WBC count \<4000 cells/mm3 or \>12000 cells/mm3 |
Countries
South Korea
Outcome results
None listed