INSORB Versus Subcuticular Sutures at Cesarean Section
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|ClinicalTrials.gov Identifier: NCT01687972|
Recruitment Status : Terminated (insufficient recruitment)
First Posted : September 19, 2012
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section Pregnancy||Combination Product: Insorb absorbable staples Combination Product: Absorbable sutures||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Skin Closure at Cesarean Section: INSORB Absorbable Staples Versus Subcuticular Sutures|
|Actual Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
|Active Comparator: Sutures||
Combination Product: Absorbable sutures
placement of absorbable sutures at cesarean section
|Active Comparator: Insorb Staples||
Combination Product: Insorb absorbable staples
Placement of Insorb absorbable staples at cesarean section
- Patient Pain Scale [ Time Frame: 3 months ]Visual Analog Score 0-10, with 0 being painless and 10 being the most severe
- Patient Scar Assessment Scale (PSAS) [ Time Frame: 6 weeks ]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.
- Closure Time [ Time Frame: up to 20 minutes post intervention ]Number of minutes taken to close post cesarean section
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687972
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 20794|