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COMPLETED
NCT07545187
PHASE1/PHASE2

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

Sponsor: Alaa Nadhim Hameed

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-06-01

Completion Date

2026-04-15

Last Updated

2026-04-28

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Kirkuk, Medical Collage

Kirkuk, Kirkuk Governorate, Iraq