Clinical trial NCT01687972: INSORB Versus Subcuticular Sutures at Cesarean Section
Official title: A Randomized Controlled Trial of Skin Closure at Cesarean Section: INSORB Absorbable Staples Versus Subcuticular Sutures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cesarean Section
Pregnancy
Keywords: cesarean section
insorb staples
absorbable staples
transverse skin incision
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 187
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* cesarean section via transverse skin incision informed consent

Exclusion Criteria:

* vertical skin incision

Primary outcomes:
measure: Patient Pain Scale
timeFrame: 3 months
measure: Patient Scar Assessment Scale (PSAS)
timeFrame: 6 weeks
measure: Closure Time
timeFrame: up to 20 minutes post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References:
citation: Chelmow D, Rodriguez EJ, Sabatini MM. Suture closure of subcutaneous fat and wound disruption after cesarean delivery: a meta-analysis. Obstet Gynecol. 2004 May;103(5 Pt 1):974-80. doi: 10.1097/01.AOG.0000124807.76451.47.
citation: Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.
citation: Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.
citation: Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.
citation: Couto RC, Pedrosa TM, Nogueira JM, Gomes DL, Neto MF, Rezende NA. Post-discharge surveillance and infection rates in obstetric patients. Int J Gynaecol Obstet. 1998 Jun;61(3):227-31. doi: 10.1016/s0020-7292(98)00047-2.
citation: Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.