INSORB Versus Subcuticular Sutures at Cesarean Section

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Janice Henderson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01687972
First received: September 9, 2012
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Cesarean Section
Pregnancy
Device: Insorb absorbable staples
Device: Absorbable sutures
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Skin Closure at Cesarean Section: INSORB Absorbable Staples Versus Subcuticular Sutures

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Composite wound complication rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Wound separation, seroma or hematoma requiring wound opening or antibiotics, wound infection requiring antibiotics or opening of incision, unexpected visits to doctor or hospital for wound issues


Secondary Outcome Measures:
  • Patient satisfaction with scar [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessed using the Patient scar assessment score

  • Patient pain scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Objective scar score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    assessed using the Objective scare score scale

  • Closure time [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: May 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sutures Device: Absorbable sutures
placement of absorbable sutures at cesarean section
Active Comparator: Insorb Staples Device: Insorb absorbable staples
Placement of Insorb absorbable staples at cesarean section

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 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

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cesarean section via transverse skin incision informed consent

Exclusion Criteria:

  • vertical skin incision
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687972

Contacts
Contact: Christopher P Wayock, MD 5167178904 cwayock1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 20794
Contact: Christopher P Wayock    516-717-8904    cwayock1@jhmi.edu   
Principal Investigator: Janice Henderson, MD         
Sub-Investigator: Christopher P Wayock, MD         
Sponsors and Collaborators
Johns Hopkins University
  More Information

Publications:
Responsible Party: Janice Henderson, Assistant Professor, Johns Hopkins School of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01687972     History of Changes
Other Study ID Numbers: NA_00043795
Study First Received: September 9, 2012
Last Updated: September 14, 2012
Health Authority: United States: Office of Human Subjects Research
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
cesarean section
insorb staples
absorbable staples
transverse skin incision

ClinicalTrials.gov processed this record on September 16, 2014