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.

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.

Female with singleton term pregnancy

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.

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.

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.

Participants were randomly assigned in a 1:1 ratio to one of two groups. The random sequence was generated before enrollment by computer-generated random numbers, and allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes. Because the intervention regimen involved two sequential applications in one group and a single topical application in the other group, participant blinding was not feasible. The study was therefore conducted as an assessor-blinded trial; the investigator who measured REEDA and VAS outcomes at follow-up visits was not involved in treatment allocation and was unaware of group assignment.