Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection

• ClinicalTrials.gov Identifier: NCT02396329
• Recruitment Status: Unknown
• First Posted: March 24, 2015
• Last Update Posted: March 24, 2015
• Sponsor: Ain Shams Maternity Hospital
• Information provided by (Responsible Party): AMR HELMY YEHIA, Ain Shams Maternity Hospital

Study Description

Brief Summary:

There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.

Condition or disease	Intervention/treatment	Phase
Surgical Site Infection	Drug: Chlorhexidine; Drug: Povidone-Iodine	Phase 2

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 410 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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

Arms and Interventions

Arm	Intervention/treatment
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. .	Drug: Chlorhexidine
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	Drug: Povidone-Iodine; Other Name: Betadine

Outcome Measures

Primary Outcome Measures :

1. Surgical site infection within one week after surgery [ Time Frame: One week ]

Secondary Outcome Measures :

1. Surgical site infection within 30 days after surgery [ Time Frame: in 30 days ]
2. Long hospital stay [ Time Frame: 30 days ]
   hospital admission for more than 5 days
3. Hospital readmission [ Time Frame: 30 days ]
   readmission due to sepsis
4. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 42 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation).
2. Body mass index (BMI) between 20-35kg/m2.
3. Able to communicate well with the investigator and to comply with the requirements of the entire study.

Exclusion Criteria:

1. Rupture of membranes.
2. Patients who have history of allergy to chlorhexidine, alcohol and iodophors.
3. Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.

Contacts and Locations

Contacts

Contact: AMR YEHIA, MD, MRCOG; +201227900014; am_helmy77@hotmail.com

Locations

Egypt

Ain Shams Maternity Hospital; Recruiting

Cairo, Egypt, 11566

Contact: AMR YEHIA, MD, MRCOG +201227900014 am_helmy77@hotmail.com

Sponsors and Collaborators

Ain Shams Maternity Hospital

Investigators

• Study Director: AMR YEHIA, MD, MRCOG; Ain Shams Maternity Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.

• Responsible Party: AMR HELMY YEHIA, MD,MRCOG, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT02396329
• Other Study ID Numbers: antisepsis 1
• First Posted: March 24, 2015
• Last Update Posted: March 24, 2015
• Last Verified: March 2015

Additional relevant MeSH terms:

Infections; Communicable Diseases; Surgical Wound Infection; Disease Attributes; Pathologic Processes; Wound Infection; Postoperative Complications; Chlorhexidine; Povidone-Iodine; Povidone; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Plasma Substitutes; Blood Substitutes