Betadine Irrigation in Cesarean Section
Condition: Infection; Cesarean Section
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate, for the first time in Literature, the effects of
      betadine washing versus normal saline washing after uterine closure in women undergoing
      cesarean section (CS) at ≥36 gestational weeks in terms of post CS infections, complication,
      fever and pain.
    

Detailed description: 
      This was a single-centre randomized controlled trial performed at Department of Obstetrics
      and Gynecology of San Camillo Hospital of Rome. The protocol was approved by the Internal
      Review Board. All women having a cesarean section (CS) were eligible for recruitment unless
      there was suspected or known allergy to iodine. The study was widely publicized around
      obstetrics unit and all women were provided antenatally with a brief statement regarding the
      study. The study was presented to women as part of hospital initiative to reduce
      postoperative infections and to improve postoperative recovery. Consent was obtained from all
      women at the time of consenting for CS.

      Background was recorded for each patient: maternal age, gestational week at delivery, BMI,
      and pregnancy complication; plural fetal pregnancies, premature rupture of membranes,
      placenta previa and pre-eclampsia. The investigators recorded the type of cesarean procedure,
      elective (scheduled operations) or urgent (patients in labor and maternal or fetal emergent
      indication), mean surgical time to perform CS.

      In Literature, povidone-iodine irrigation has been demonstrated to be a simple and
      inexpensive solution with the potential to prevent surgical site infection , which can also
      reduce the incidence of intra-abdominal infectious complications when used as an
      intraperitoneal irrigant in patients undergoing bacterially-contaminated surgical procedures,
      i.e. orthopedic, general surgery, oncologic surgery. Therefore, the investigators aimed to
      test its use in CS.

      Patients were intra-operatively randomized to receive intraperitoneal irrigation prior to
      abdominal closure with low molecular weight povidone-iodine solution ('Betadine LMW') (PVP-I
      LMW) diluted 50:50 with normal saline or with only normal saline solution. Randomization to
      'Betadine' or 'no Betadine' group was performed using sequentially numbered sealed opaque
      envelopes that contained the allocation. The allocation was prepared using computer generated
      list of random numbers using a variable block of 10 and performed by a staff members, part of
      the clinical team. After all layers were sutured and just prior to starting skin closure, the
      envelope with the allocation was opened by one of the theatre nurse.

      All CS were generally performed under spinal anesthesia by the specialist obstetricians,
      credentialed trainee registrars or by juniors in the presence of a specialist obstetrician
      using the modified Misgav Ladach surgical technique.

      An abdominal opening was made through a straight transverse incision, which was placed 3-4 cm
      above the symphysis. The subcutaneous tissue was left untouched apart from the midline. The
      rectus sheath was separated along its fibers and the rectus muscles separated by pulling.
      Stretching with index fingers opened the peritoneum and the uterus was opened with an index
      finger. The hole was enlarged between the index finger of one hand and the thumb of the
      other.

      Single-layer closure of the uterine incision was performed as follows: a holding Vicryl-0 was
      placed in the left corner to stabilize and define the demarcation of the suture line. A
      continuous non-locking stitch beginning at the right corner was used, closing the whole
      thickness of the uterine wall, excluding the decidual layer, in a cranial/caudal position.
      Additional single sutures were added for hemostasis if required. Routinely exteriorization of
      the uterus was not performed. The visceral and parietal peritoneal layers were left open and
      the rectus muscle was not stitched. The rectus sheath was stitched with a continuous
      non-locking Vicryl-0 and the subdermal space was closed in all patients. All patients had
      preoperative exams not longer than 4 weeks prior the CS and received prophylactic intravenous
      antibiotics (amoxicillin 2 g and metronidazole 1 g) preoperatively to reduce the rate of
      wound infection. In addition, all patients received oxytocin intravenous during CS and 20 IU
      was administered by an intravenous drip running post surgical procedure. All patients were
      encouraged to start breastfeeding during early postoperative care, supported by a midwife and
      by a nurse specialized in newborn care after admission to the maternity ward.

      Post CS infections included:

        -  Postpartum endometritis: defined as a clinical diagnosis, usually involving fever,
           uterine fundal tenderness, or purulent lochia requiring antibiotic therapy.

        -  Postoperative wound infection: defined as erythema, tenderness, purulent drainage from
           the incision site, with or without fever, requiring antibiotic therapy.

        -  Postoperative fever: defined as greater than 38 degrees C or 100.4 degrees F.

        -  Postoperative wound seroma or hematoma: defined as collection of serous fluid or
           blood/clot in the subcutaneous area of the incision.

        -  Composite wound complications: defined as the presence of any one of the following:
           wound infection, seroma, hematoma, separation.

      Patients were examined during daily rounds whilst in hospital about intestinal
      recanalization, postoperative mobilization, postoperative 24h post CS pain and wounds.
      Preoperative and postoperative exams, presence of fever or any symptoms have been accurately
      registered.

      After discharge from the hospital, the women were sent a letter with addressed return
      envelope to report any post CS problems at four weeks after surgery as part of hospital
      surveillance policy. Charts of all women readmitted for any reason were reviewed. Differences
      between 'Betadine' and 'no Betadine' groups were assessed using chi square for categorical
      data test. Fisher's exact test was used where there were 5 or fewer counts within a category
      and t-test for continuous data. Relative risk (RR) and the corresponding 95% confidence
      interval (CI) were calculated. A P value of <0.05 was considered statistically significant.
    

Intervention name(s): betadine group; no betadine group
Intervention type(s): Other; Other
Intervention description(s): Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with low molecular weight povidone-iodine solution ('Betadine LMW') (PVP-I LMW) diluted 50:50 with normal saline.; Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with only normal saline solution.
Intervention MeSH terms: Povidone-Iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: cesarean section; cesarean section complications; betadine irrigation