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Staples Versus Dermabond for Closure of the Skin After Cesarean Section

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Meir Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01261715
First Posted: December 16, 2010
Last Update Posted: December 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Meir Medical Center
  Purpose

Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures.

Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds.


Condition Intervention Phase
Cesarean Section Wound Procedure: Dermabond- liquid skin adhesive Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Staples Versus Dermabond for Closure of the Skin After Cesarean Section

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Cosmetic objective evaluation of the scar [ Time Frame: 6 weeks postoperatively ]

Secondary Outcome Measures:
  • The difference in pain between the two type of closure [ Time Frame: 1 and 4 days postoperatively ]
  • The difference in patient satisfaction with the scar result [ Time Frame: 6 weeks postoperatively ]

Enrollment: 50
Study Start Date: January 2011
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Woman with previous ceasarean section - staples Procedure: Dermabond- liquid skin adhesive
Dermabond- liquid skin adhesive

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Woman over 18 year Woman having elective caesarean section

Exclusion Criteria:

Age under 18 Woman having an emergency caesarean section

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01261715


Locations
Israel
Meir medical center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Dana Sadeh, MD MD
  More Information

Responsible Party: Sadeh Dana MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01261715     History of Changes
Other Study ID Numbers: 155-2010
First Submitted: December 6, 2010
First Posted: December 16, 2010
Last Update Posted: December 16, 2010
Last Verified: October 2010