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Chlorhexidine-alcohol versus povidone-iodine for skin and vaginal prep before cesarean section

Comparison of the effect of chlorhexidine-alcohol-based solution (Hisept Surgiguard) for skin prep and chlorhexidine-based solution (Septibody) for vaginal prep versus povidone-iodine (Betadine) before elective cesarean section in preventing surgical site infection: A randomized clinical trial study with factorial design

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220408054454N3
Enrollment
800
Registered
2025-07-30
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean surgical wound. Infection of obstetric surgical wound

Interventions

Intervention 1: Intervention group A: Skin and vaginal prep, both chlorhexidine. Intervention 2: Intervention group B: Skin and vaginal prep, both Betadine. Intervention 3: Intervention group C: Chlor

Sponsors

Dana Pharmed Lotus
Lead Sponsor
Tehran University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Singleton pregnancy Prior planning for cesarean section and elective cesarean section Planned gestational age of at least 36 weeks at time of delivery• Written informed consent provided Intention to be available for the entire study period and complete all relevant study procedures, including follow-up visits and telephone calls Hemoglobin greater than 10 g/dL at time of admission

Exclusion criteria

Exclusion criteria: Body mass index greater than or equal to 40 at study entry Placenta previa or placental adhesions Previous intestinal or urological surgery Multiple pregnancy Known or suspected impairment of immunologic function, including infection with HIV, hepatitis B, or C Use of immunosuppressive drugs, chemotherapy, radiotherapy, or systemic corticosteroids within 4 weeks prior to surgery Known use of tobacco or narcotics and stimulants Any condition that, in the investigator's opinion, may pose a risk to the participant's health or interfere with the assessment of the study objectives. History of keloid or scar formation Participation in another clinical trial within the past three months Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, or psychological disease as determined by the physician Frequent vaginal swab examinations Emergency cesarean section Chorioamnionitis or other systemic infection at the time of presentation for cesarean section, including evidence of perianal skin infection (e.g., fungal infection)

Design outcomes

Primary

MeasureTime frame
Surgical wound infection. Timepoint: Days 2, 10 and 30 after surgery. Method of measurement: According to the doctor's diagnosis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmene Abiri

Tehran University of Medical Sciences

abiri@sina.tums.ac.ir+98 912 709 0424

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026