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

NCT02396329 | Unknown Phase 2 DMC

• 1 other identifier: antisepsis 1
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Surgical site infection within one week after surgery

  One week

Secondary Outcomes (4)

• Surgical site infection within 30 days after surgery

  in 30 days

• Long hospital stay

  30 days

• Hospital readmission

  30 days

• Febrile morbidity

  10 days

Study Arms (2)

chlorhexidine _based antisepsis

EXPERIMENTAL

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

povidone_iodine based antisepsis

ACTIVE COMPARATOR

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

Interventions

Chlorhexidine DRUG

chlorhexidine _based antisepsis

Povidone-Iodine DRUG

Also known as: Betadine

povidone_iodine based antisepsis

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, 11566, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 32580252 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Chlorhexidine; Povidone-Iodine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• AMR YEHIA, MD, MRCOG

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

AMR YEHIA, MD, MRCOG

CONTACT

+201227900014; am_helmy77@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,MRCOG

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 24, 2015
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

EG (1)