Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02865993 |
| Other study ID # |
BetadineCS0405 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
July 27, 2016 |
| Last updated |
August 12, 2016 |
| Start date |
September 2015 |
| Est. completion date |
June 2016 |
Study information
| Verified date |
July 2016 |
| Source |
Campus Bio-Medico University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Italy: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial 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.
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.
