Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection
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|ClinicalTrials.gov Identifier: NCT02396329|
Recruitment Status : Unknown
Verified March 2015 by AMR HELMY YEHIA, Ain Shams Maternity Hospital.
Recruitment status was: Recruiting
First Posted : March 24, 2015
Last Update Posted : March 24, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Drug: Chlorhexidine Drug: Povidone-Iodine||Phase 2|
The aim of this study is to examine the efficacy &safety of Chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection.Chlorhexidine is a chemical antiseptic. It is effective on both Gram-positive and Gram-negative bacteria, although it is less effective with some Gram-negative bacteria. It has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption.
Iodine is commonly used as an antiseptic agent clinically. Iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. This formulation increases the solubility of iodine and provides a reservoir for sustained release. The most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. Iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. This leads to reduced protein synthesis and bacterial cell wall damage.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||410 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Chlorhexidine Versus Povidone-iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection Rate:a Randomized Controlled Trial|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
Experimental: chlorhexidine _based antisepsis
Including cases undergoing elective&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision.
Active Comparator: povidone_iodine based antisepsis
Including cases undergoing elective&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision
Other Name: Betadine
- Surgical site infection within one week after surgery [ Time Frame: One week ]
- Surgical site infection within 30 days after surgery [ Time Frame: in 30 days ]
- Long hospital stay [ Time Frame: 30 days ]hospital admission for more than 5 days
- Hospital readmission [ Time Frame: 30 days ]readmission due to sepsis
- Febrile morbidity [ Time Frame: 10 days ]an oral temperature of 38.0 degree Celsius)or more on any two of the first 10 days postpartum, exclusive of the first 24 hours
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|Ages Eligible for Study:||18 Years to 42 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation).
- Body mass index (BMI) between 20-35kg/m2.
- Able to communicate well with the investigator and to comply with the requirements of the entire study.
- Rupture of membranes.
- Patients who have history of allergy to chlorhexidine, alcohol and iodophors.
- Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396329
|Contact: AMR YEHIA, MD, MRCOGfirstname.lastname@example.org|
|Ain Shams Maternity Hospital||Recruiting|
|Cairo, Egypt, 11566|
|Contact: AMR YEHIA, MD, MRCOG +201227900014 email@example.com|
|Study Director:||AMR YEHIA, MD, MRCOG||Ain Shams Maternity Hospital|
|Responsible Party:||AMR HELMY YEHIA, MD,MRCOG, Ain Shams Maternity Hospital|
|Other Study ID Numbers:||
|First Posted:||March 24, 2015 Key Record Dates|
|Last Update Posted:||March 24, 2015|
|Last Verified:||March 2015|
Surgical Wound Infection
Anti-Infective Agents, Local