Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

Study Overview
=================
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.

Official Title
-----------------
Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Povidone-Iodine
* Drug: Chlorhexidine gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resection of following organs (clean-contaminated open surgery) Liver, Pancreas, Bile duct, Duodenum Stomach Colon, Small bowel 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: WBC 3000   12 000/mm3 > Hb 8.0 g/dl > Plt 100 000/mm3 < Cr 1.2 mg/dl Exclusion Criteria: allergy to chlorhexidine or povidone clean surgery or contaminated surgery patients who cannot be followed up during 1 month patients taking immunosuppressant drugs or chemotherapy agents emergent surgery and reoperation uncontrolled diabetes, BMI > 30 kg/m2 vulnerable patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Povidone Iodine<br>7.5% povidone iodine soaping 10% povidone iodine painting | Drug: Povidone-Iodine<br>* 7.5% povidone iodine soaping 10% povidone iodine painting<br>* Other names: 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM);|
| Active Comparator: Chlorhexidine Gluconate<br>4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting | Drug: Chlorhexidine gluconate<br>* 4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting<br>* Other names: 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Within 1 month | 
| Number of patients with the postoperative sepsis induced by wound infection | Definition of Sepsis Proven infection (by culture, stain) or a clinical syndrome pathognomonic for infection (WBC, imaging finding or petechiae, purpura, or purpura fulminans) Body temperature (<36 or >38 Celsus Degree) Heart rate > 90 beats per minute Respiratory rate > 20 breaths per minute or, on blood gas, a PaCO2 less than 32 mmHg WBC count <4000 cells/mm3 or >12000 cells/mm3 | within 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
povidone iodine, surgical site infection, chlorhexidine gluconate