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Staples Versus Dermabond for Closure of the Skin After Cesarean Section

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01261715
First received: December 6, 2010
Last updated: December 15, 2010
Last verified: October 2010
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Staples Versus Dermabond for Closure of the Skin After Cesarean Section

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Cosmetic objective evaluation of the scar [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in pain between the two type of closure [ Time Frame: 1 and 4 days postoperatively ] [ Designated as safety issue: No ]
  • The difference in patient satisfaction with the scar result [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261715

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

No publications provided

Responsible Party: Sadeh Dana MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01261715     History of Changes
Other Study ID Numbers: 155-2010
Study First Received: December 6, 2010
Last Updated: December 15, 2010
Health Authority: Israel: Clalit Health Services

ClinicalTrials.gov processed this record on May 22, 2013