Staples Versus Dermabond for Closure of the Skin After Ce... | NCT01261715

Studies
Staples Versus Dermabond for Closure of the Skin After Cesarean Section

NCT01261715

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Dec 16, 2010Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Cesarean Section Wound

Interventions

Dermabond- liquid skin adhesive

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Feb 2012Estimated

Completion Date

Not provided

First Submitted Date

Dec 6, 2010

First Submission Date that Met QC Criteria

Dec 15, 2010

First Posted Date

Dec 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2010

Last Update Posted Date

Dec 16, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Woman with previous ceasarean section - staples	Active Comparator		Procedure: Dermabond- liquid skin adhesive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dermabond- liquid skin adhesive	Procedure	Dermabond- liquid skin adhesive	Woman with previous ceasarean section - staples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cosmetic objective evaluation of the scar		6 weeks postoperatively

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Woman over 18 year Woman having elective caesarean section

Exclusion Criteria:

Age under 18 Woman having an emergency caesarean section

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided