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INSORB Versus Subcuticular Sutures at Cesarean Section

NCT01687972 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2018-04-02

Study results available
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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.

Conditions

  • Cesarean Section
  • Pregnancy

Interventions

COMBINATION_PRODUCT

Insorb absorbable staples

Placement of Insorb absorbable staples at cesarean section

COMBINATION_PRODUCT

Absorbable sutures

placement of absorbable sutures at cesarean section

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01687972 on ClinicalTrials.gov