A Phase 1/2 interventional study of Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone in Surgical Site Infection Prevention, Episiotomy Infection and Episiotomy Wound, sponsored by Alaa Nadhim Hameed. Completed at 1 site in Iraq. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Alaa Nadhim Hameed · Phase 1/2, Interventional, and Prevention
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.
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.
This is the only study on the registry with Alaa Nadhim Hameed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 10 days
pain intensity
Secondary outcomes included pain intensity measured using a 10-cm visual analogue scale on the same follow-up days
Time frame: 10 days
sexual activity
Time to resumption of sexual activity assessed at 12 weeks postpartum
Time frame: 12 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.