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

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.

Study Overview

• Status: Completed
• Conditions: Episiotomy Wound; Normal Vaginal Delivery; Episiotomy Infection; Surgical Site Infection Prevention
• Intervention / Treatment: Drug: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone

Detailed Description

Group 1 received sequential topical diltiazem gel followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone. In Group 1, diltiazem gel was first applied to the sutured episiotomy twice daily for 10 days post delivery. After approximately 15 minutes, fusidic acid cream was applied to the same area. In Group B, fusidic acid cream alone was applied to the episiotomy wound twice daily for 10 days postpartum. Both groups received the same routine postpartum care instructions.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Kirkuk Governorate
    • Kirkuk, Kirkuk Governorate, Iraq, 36001
      • University of Kirkuk, Medical Collage

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: diltiazem and fusidic acid; 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; lower the risk of or prevent surgical site infection after episiotomy repair.
Active Comparator: fusidic acid cream alone; 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; lower the risk of or prevent surgical site infection after episiotomy repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	Secondary outcomes included pain intensity measured using a 10-cm visual analogue scale on the same follow-up days	10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sexual activity	Time to resumption of sexual activity assessed at 12 weeks postpartum	12 weeks

Collaborators and Investigators

• Sponsor: Alaa Nadhim Hameed

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trail; preventing surgical site infection after episiotomy
• Other Study ID Numbers: 1986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The following de-identified individual participant data (IPD) will be shared:

• Demographic variables (age, BMI, education, employment status).
• Obstetric and delivery data (gestational age, birth weight, duration of second stage, episiotomy type, mode of delivery, pregnancy complications).
• Treatment allocation group (diltiazem + fusidic acid vs fusidic acid alone).
• REEDA scores on postpartum days 3, 7, and 10.
• VAS pain scores on postpartum days 3, 7, and 10.
• Use of oral analgesics during the first 10 postpartum days (yes/no, type, approximate frequency).
• Occurrence of wound complications (infection, dehiscence, other adverse events).
• Sexual activity outcomes at 12 weeks postpartum (resumption of intercourse, yes/no, week of resumption, pain during intercourse scores, self-reported impact on sexual life).

All data will be de-identified; no direct identifiers (name, address, phone number, ID number) will be shared.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No