INSORB Versus Subcuticular Sutures at Cesarean Section
INSORB Versus Subcuticular Sutures at Cesarean Section
The proposed study is a randomized controlled trial with two arms. All patients admitted to
 Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered
 entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section,
 the patient will be randomized at time of cesarean section to receive skin closure by either
 the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the
 standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment
 score (PSAS) will be obtained during this visit. The patient will then be contacted by
 telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey)
 assessing her satisfaction with the resulting scar.
The proposed study is a randomized controlled trial with two arms. All patients admitted to
 Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered
 entry into our study during the routine consent process which includes consent for cesarean
 section that occurs with each patient. Once the patient is enrolled, and if she undergoes a
 cesarean section, the patient will be randomized at time of cesarean section to receive skin
 closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture
 as is the standard practice. The size of the suture (3-0 vs. 4-0) and type of needle used to
 sew is at the discretion of the surgeon. The indications for and performance of the cesarean
 section will remain standard care by the Obstetrical team and the patient's participation in
 this study will have no impact whatsoever on the obstetrical course of the patient. The only
 additional procedure that will be asked of the obstetrical team performing the cesarean
 section is to measure and close the subcutaneous tissue if the depth from the skin edge to
 the transversalis fascia is greater than 2cm as this has been shown to decrease subsequent
 seroma formation and wound disruption. The dressing will be standardized as follows: a folded
 abdominal (ABD) pad will be placed in a sterile fashion directly over the incision and foam
 tape will be applied to provide a "pressure dressing." The dressing will be removed on
 post-operative day #2.

 The patient's postoperative course will remain unchanged and her discharge will be at the
 discretion of her obstetrical providers. On post-operative day #3, a picture of the incision
 will be taken with the patient's identifying number adjacent to the picture and the patient
 will be asked to complete a brief survey asking about post-operative pain and scars (see
 included PSAS survey). The patients will follow-up with her Obstetrician for her normal
 post-partum visit where another picture of the incision will be taken. Both an observer scar
 assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this
 visit. The patient will then be contacted by telephone by a study member 3 months after her
 surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting
 scar. At this point, the patient's participation in the study will end.
Inclusion Criteria:

 -  cesarean section via transverse skin incision informed consent

 Exclusion Criteria:

 -  vertical skin incision