Episiotomy Infection, Episiotomy Wound, Normal Vaginal Delivery, Surgical Site Infection Prevention
Conditions
Keywords
randomized controlled trail, preventing surgical site infection after episiotomy
Brief 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.
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.
Interventions
DRUGGroup 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.
Sponsors
Alaa Nadhim Hameed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing | 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
| Measure | Time frame | Description |
|---|---|---|
| pain intensity | 10 days | Secondary outcomes included pain intensity measured using a 10-cm visual analogue scale on the same follow-up days |
Countries
Iraq
Outcome results
None listed