Surgical Site Infection PreventionPhase 1/2NCT07545187
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
A Phase 1/2 study testing Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone in people with Surgical Site Infection Prevention and Episiotomy Infection, run by Alaa Nadhim Hameed at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Surgical Site Infection Prevention, Episiotomy Infection, Episiotomy Wound
- What is being tested?
- Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2025to 15 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primiparous women
- Singleton term pregnancy.
- Vaginal delivery with mediolateral episiotomy.
- Willingness to participate and provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
University of Kirkuk, Medical Collage
Kirkuk, Kirkuk Governorate, 36001
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Surgical Site Infection Prevention, Episiotomy Infection, Episiotomy Wound, Normal Vaginal Delivery
- Being tested
- Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone
- Keywords
- randomized controlled trail, preventing surgical site infection after episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream aloneDrug
lower the risk of or prevent surgical site infection after episiotomy repair.
| Study group | Role | What they receive |
|---|---|---|
| diltiazem and fusidic acid | Active comparator | patients in this group received sequential topical diltiazem gel 2% followed by fusidic acid cream> Receives: 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 Receives: Drug: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (1)
pain intensity
Secondary outcomes included pain intensity measured using a 10-cm visual analogue scale on the same follow-up days
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jun 2025
- Primary completion10 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Nadhim Hameed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Nadhim Hameed, University of Kirkuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545187
- Sponsor's protocol ID
- 1986
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07545187
- Acronym / sponsor ID
- 1986
- Conditions
- Surgical Site Infection Prevention, Episiotomy Infection, Episiotomy Wound, Normal Vaginal Delivery
- Keywords
- randomized controlled trail, preventing surgical site infection after episiotomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alaa Nadhim HameedUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diltiazem and fusidic acid | Active comparator | Drug: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alonepatients in this group received sequential topical diltiazem gel 2% followed by fusidic acid cream> |
| fusidic acid cream alone | Active comparator | Drug: Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alonePatients in this group received topical fusidic acid cream alone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primiparous women
- Singleton term pregnancy.
- Vaginal delivery with mediolateral episiotomy.
- Willingness to participate and provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alonelower the risk of or prevent surgical site infection after episiotomy repair. | Drug | diltiazem and fusidic acid, fusidic acid cream alone |
Primary outcome
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.
1 secondary outcome
pain intensity
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group 1 received sequential topical diltiazem gel 2% followed by fusidic acid cream, and Group 2 received topical fusidic acid cream alone in people with Surgical Site Infection Prevention and Episiotomy Infection, run by Alaa Nadhim Hameed at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.