INSORB Versus Subcuticular Sutures at Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Skin Closure at Cesarean Section: INSORB Absorbable Staples Versus Subcuticular Sutures

Conditions
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Cesarean Section, Pregnancy

Intervention / Treatment
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* Combination Product: Insorb absorbable staples
* Combination Product: Absorbable sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cesarean section via transverse skin incision informed consent Exclusion Criteria: vertical skin incision

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sutures<br> | Combination Product: Absorbable sutures<br>* placement of absorbable sutures at cesarean section<br>|
| Active Comparator: Insorb Staples<br> | Combination Product: Insorb absorbable staples<br>* Placement of Insorb absorbable staples at cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Pain Scale | Visual Analog Score 0-10, with 0 being painless and 10 being the most severe | 3 months | 
| Patient Scar Assessment Scale (PSAS) | assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin. | 6 weeks | 
| Closure Time | Number of minutes taken to close post cesarean section | up to 20 minutes post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, insorb staples, absorbable staples, transverse skin incision