Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

NCT ID: NCT02831946

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Adhesive; Band Suture; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MODIFIED VICRYL PLUS

The intra-cuticular layer will closed with with VICRYL PLUS suture

Group Type EXPERIMENTAL

MODIFIED VICRYL PLUS

Intervention Type DEVICE

closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture

DERMABOND GLUE

The intra-cuticular layer will closed with with DERMABOND GLUE

Group Type EXPERIMENTAL

DERMABOND GLUE

Intervention Type DEVICE

closing the intra-cuticular layer with Dermabond glue

Interventions

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MODIFIED VICRYL PLUS

closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture

Intervention Type DEVICE

DERMABOND GLUE

closing the intra-cuticular layer with Dermabond glue

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yair Daykan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reut Ohana

Role: PRINCIPAL_INVESTIGATOR

Meir Helsinki

Locations

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Meir Medical Center

Kfar Saba, Israel, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yair M Daykan, MD

Role: CONTACT

972-542198231

Reut Ohana

Role: CONTACT

972-9-7471588

Facility Contacts

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Yair M Daykan, MD

Role: primary

972-54-2198231

Other Identifiers

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0062-16-MMC

Identifier Type: -

Identifier Source: org_study_id

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