Infection Control / Methods, Surgical Site Infection (SSI)
Conditions
Brief summary
To evaluate the effects of preoperative prophylactic administration of clindamycin vaginal cream compared to preoperative vaginal cleansing using a 10% povidone-iodine solution on postpartum infectious morbidity.
Detailed description
All patients (interventions and control group) are informed not to practice coitus, or use any vaginal products (such as douches, tampons or any type of pessary) during the period of intervention. Also, no vaginal examination was performed to all participants within 3 days of the CS. The circulating nurse will clean the skin to all participants by following the manufacturer's guidelines. The antiseptic (Povidone-Iodine) is opened, and the surgical site is scrubbed with it. A period of waiting for 3 min was allowed between the application of the antiseptic agent and skin incision to allow the adhesive surgical drapes to stick properly over dry skin. The skin of all eligible individuals is aseptically treated in the same technique, using the same materials in an equal amount to control variances. All the enrolled participants receive the same health education and wound care advice from the professional health team. All participants will be given spinal anesthesia. Patients are catheterized with Foley's catheter no 16 F under complete aseptic conditions then abdominal scrub is performed as usual using povidone iodine. Pfannenstiel incision is performed as usual. Transverse incision is performed in the lower uterine segment followed by delivery of the baby and the placenta and membrane. Antibiotics are given according to hospital protocol (ceftriaxone 1gm and metronidazole iv /12 hours in first 24 hours starting within 1 hour from skin incision ) followed by Amoxicillin -clavulanic acid for 5 days after discharge Follow up after cesarean section * All patients receive routine postoperative care without further interventions. * All patients are advised to return to hospital if they develop symptoms of infections such as hotness of the body, foul smelling vaginal discharge, persistent/increasing lower abdominal pain, wound discharge, swelling, redness, or dehiscence
Interventions
DRUGClindamycin vaginal cream
Clindamycin vaginal cream one applicator each night for 3 nights before CS.
DRUGVaginal preparation with povidone- iodide solution 10 %
Vaginal preparation with povidone- iodide solution 10 %
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* female participants with singleton pregnancies scheduled for elective cesarean sections at term, specifically between 37 and 40 weeks of gestation * free from any medical disorders. * The participants' ages ranged from 18 to 40 years * body mass index (BMI) ranged from 18 to 30 kg/m2
Exclusion criteria
1. Cases of urgent or emergent CS. 2. Abnormal vaginal secretion (bad smelling yellowish secretion, whitish cheesy discharge with pruritus, bloody discharge; etc…). 3. Women with medical disorders such as pre-gestational diabetes, anemia, hypertension, preeclampsia, or immunosuppressant pregnant women. 4. Women who had a skin infection adjacent to the operative site. 5. Allergy to topical povidone-iodine or clindamycin 6. Feverish patients or history of premature rupture of membranes or with placenta previa. 7. patients lost during follow-up were excluded from the final analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound infection (surgical site infection SSI) | 3 weeks | erythema, tenderness or wound edge separation with purulent discharge involving the cesarean incision site. |
Countries
Egypt
Contacts
CONTACTSara Abdallah Salem, MD
Outcome results
None listed