Suture Versus Glue (Dermabond) Closure During Cesarean De... | NCT02831946

Studies
Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

NCT02831946

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Jul 13, 2016Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Adhesive; Band
Suture; Complications

Interventions

MODIFIED VICRYL PLUS
DERMABOND GLUE

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

May 2017Estimated

Completion Date

Feb 2018Estimated

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Jul 11, 2016

First Posted Date

Jul 13, 2016Estimated

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

Jul 11, 2016

Last Update Posted Date

Jul 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.

Detailed Description

Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.

Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.

Data were analyzed according to the intention to treat principle.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MODIFIED VICRYL PLUS	Experimental	The intra-cuticular layer will closed with with VICRYL PLUS suture	Device: MODIFIED VICRYL PLUS
DERMABOND GLUE	Experimental	The intra-cuticular layer will closed with with DERMABOND GLUE	Device: DERMABOND GLUE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MODIFIED VICRYL PLUS	Device	closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture	MODIFIED VICRYL PLUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient and Observer Scar Assessment Scale (POSAS)	Subjective scar rating will be performed using the patient component of the POSAS. The POSAS Scale consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale	2 month

Secondary Outcomes

Measure	Description	Time Frame
post operative complication	Development of surgical site infection or wound disruption.	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women between 18 and 45 years
Elective cesarian section

Exclusion Criteria:

Clinical signs of infection at the time of CS
History of keloids and a medical disorder that could affect wound healing
Hypersensitivity to any of the suture materials used in the protocol
Diabetes mellitus
Disorders requiring chronic corticosteroid use or immunosuppression

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yair M Daykan, MD	Contact	972-542198231		yair.dykan@gmail.com
Reut Ohana	Contact	972-9-7471588		reut.ohana@clalit.org.il

Overall Officials

Name	Affiliation	Role
Reut Ohana	Meir Helsinki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center	Recruiting	Kfar Saba	Israel	11125	Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

within 6 m of finishing the study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided