NCT01261715

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Last Updated

December 16, 2010

Status Verified

October 1, 2010

Enrollment Period

1.1 years

First QC Date

December 6, 2010

Last Update Submit

December 15, 2010

Conditions

Cesarean Section Wound

Outcome Measures

Primary Outcomes (1)

  • Cosmetic objective evaluation of the scar

    6 weeks postoperatively

Secondary Outcomes (2)

  • The difference in pain between the two type of closure

    1 and 4 days postoperatively

  • The difference in patient satisfaction with the scar result

    6 weeks postoperatively

Study Arms (1)

Woman with previous ceasarean section - staples

ACTIVE COMPARATOR
Procedure: Dermabond- liquid skin adhesive

Interventions

Dermabond- liquid skin adhesivePROCEDURE

Dermabond- liquid skin adhesive

Woman with previous ceasarean section - staples

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman over 18 year Woman having elective caesarean section

You may not qualify if:

  • Age under 18 Woman having an emergency caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, Israel

Location

Study Officials

  • Dana Sadeh, MD

    MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 16, 2010

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Last Updated

December 16, 2010

Record last verified: 2010-10

Locations

IL(1)