Effect of Topical Diltiazem Plus Fusidic Acid Versus Fusidic Acid Alone on Episiotomy Healing, Pain, and Resumption of Sexual Activity: A Randomized Controlled Trial in Azadi Teaching Hospital

NCT07545187 | Completed Phase 1

• 1 other identifier: 1986
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if diltiazem gel combined with fucidic acid cream works better than fucidic acid cream alone to prevent surgical site infection following episiotomy repair. It will also learn about the safety of this regimen. The main questions it aims to answer are: Does diltiazem gel combined with fucidic acid cream lower the incidence of surgical site infection? What medical problems do participants have when taking this regimen? Researchers will compare whether diltiazem gel combined with fucidic acid cream versus the fucidic acid cream alone to see if the first protocol works better? Participants will: Apply diltiazem gel combined with fucidic acid cream twice/day for 10 days Visit the clinic on days 3, 7, and 10 for checkups and tests Keep a diary of their symptoms and the number of times they use the regimen.

Conditions

Episiotomy Infection; Episiotomy Wound; Normal Vaginal Delivery; Surgical Site Infection Prevention

Keywords

randomized controlled trail; preventing surgical site infection after episiotomy

Outcome Measures

Primary Outcomes (1)

• wound healing

  The primary outcome was wound healing as assessed by the REEDA scale on postpartum. It measures five key indicators-Redness, Edema, Ecchymosis, Discharge, and Approximation-with a lower score indicating better healing and higher scores showing impaired healing.

  10 days

Secondary Outcomes (1)

• pain intensity

  10 days

Other Outcomes (1)

• sexual activity

  12 weeks

Study Arms (2)

diltiazem and fusidic acid

ACTIVE COMPARATOR

patients in this group received sequential topical diltiazem gel 2% followed by fusidic acid cream\>

Drug: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone

fusidic acid cream alone

ACTIVE COMPARATOR

Patients in this group received topical fusidic acid cream alone

Drug: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone

Interventions

Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone DRUG

lower the risk of or prevent surgical site infection after episiotomy repair.

diltiazem and fusidic acid; fusidic acid cream alone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female with singleton term pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous women
• Singleton term pregnancy.
• Vaginal delivery with mediolateral episiotomy.
• Willingness to participate and provide informed consent.

You may not qualify if:

• Known hypersensitivity to diltiazem or fusidic acid.
• Pre-existing local perineal infection.
• Chronic systemic disease likely to impair wound healing, including uncontrolled diabetes or immunosuppressive conditions.

Sponsors & Collaborators

• Alaa Nadhim Hameed: lead

Study Sites (1)

University of Kirkuk, Medical Collage

Kirkuk, Kirkuk Governorate, 36001, Iraq

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were randomly assigned in a 1:1 ratio to one of two groups. The random sequence was generated before enrollment by computer-generated random numbers, and allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes. Because the intervention regimen involved two sequential applications in one group and a single topical application in the other group, participant blinding was not feasible. The study was therefore conducted as an assessor-blinded trial; the investigator who measured REEDA and VAS outcomes at follow-up visits was not involved in treatment allocation and was unaware of group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: June 1, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 15, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the main trial results and will remain available for 5 years thereafter.
• Access Criteria: De-identified IPD will be available to qualified researchers affiliated with academic or healthcare institutions who submit a methodologically sound proposal addressing a scientifically valid objective. Eligible researchers may access de-identified data for all randomized participants (including demographics, obstetric and delivery variables, treatment allocation, REEDA and VAS scores at each follow-up, analgesic use, wound complications, and 12-week sexual activity outcomes), plus supporting documents (final protocol, anonymized CRFs, and statistical analysis plan). Access will be granted after a brief written request and proposal are emailed to the corresponding author, reviewed by the principal investigator, and, if needed, the ethics committee. Approved applicants will sign a data-sharing agreement and receive password-protected electronic files, to be used only for the agreed project and not re-shared.

Locations

IR (1)