All patients, aged 18 years or older, greater than 34 weeks of gestation who will be
undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health
Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron
Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study.
Scheduled cesarean sections include all routine cesarean sections- whether receiving spinal
or general anesthesia, as well as patients who present to obstetrical triage in labor or with
ruptured membranes who are for cesarean section.
The following patients will be excluded from our study:
Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend,
failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental
abruption, prolapsed cord, etc.)
SOAT (Surgical Operative Assist Team) cesarean sections
Gestational age < 34 weeks for any reason
Preterm premature rupture of membranes from antepartum unit
As there are no published prospective trials abdominal closure bundles in cesarean sections,
sample size calculations were completed using a recently published meta-analysis of multiple
retrospective studies.4 These studies investigated various surgical site reduction techniques
as applied to cesarean sections. Using this data, which shows an average pre-intervention SSI
rate of 6% and post-reduction SSI rate of 2%, to detect a statistically significant
reduction, we will need to enroll approximately 850 patients.
Patients will be randomly assigned to receive either normal operative procedure or the
closing bundle through a randomized process. Simple randomization in a 1:1 ratio will be
completed via Microsoft Excel. Group assignments will be placed in sealed opaque envelopes
which will be located on the labor and delivery unit. The envelope will be opened by the
resident physician or advanced practice professional who will be assisting with the cesarean
section on arrival to the operating room. This will allow the scrub tech to prepare the
closing tray prior to the start of the procedure if indicated.
All patients will receive pre-operative antibiotics, chlorhexidine abdominal preparation,
thirty second betadine vaginal preparation, hair removal by clippers at the operative site,
lower extremity forced air warmer, subcutaneous tissue closure >2cm, subcuticular skin
closure, and removal of surgical bandage on post-operative day 2. The abdominal closure
bundle includes changing of the surgical gown and gloves, repeat surgical scrub, and usage of
new surgical instruments, light handles, suction, and bovie tip for closure of fascia,
subcutaneous tissue, and skin. Given the nature of the intervention, the surgeon and patient
will not be blinded to group assignment.
