Skip to main content
OpenTrials
Completed

NCT Number: NCT07545187

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Site Infection Prevention Episiotomy Infection Episiotomy Wound Normal Vaginal Delivery

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Kirkuk, Medical Collage

Kirkuk, Kirkuk Governorate, 36001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. wound healing

    Time frame: 10 days

    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.

Secondary outcomes

  1. pain intensity

    Time frame: 10 days

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

Other outcomes

  1. sexual activity

    Time frame: 12 weeks

    Time to resumption of sexual activity assessed at 12 weeks postpartum

Sponsors and collaborators

Lead sponsor

Alaa Nadhim Hameed

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.