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Suture Versus Glue (Dermabond) Closure During Cesarean Delivery (SVGCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831946
Recruitment Status : Unknown
Verified July 2016 by Yair Daykan, Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Yair Daykan, Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Adhesive; Band Suture; Complications Device: MODIFIED VICRYL PLUS Device: DERMABOND GLUE Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: MODIFIED VICRYL PLUS
The intra-cuticular layer will closed with with VICRYL PLUS suture
Device: MODIFIED VICRYL PLUS
closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture

Experimental: DERMABOND GLUE
The intra-cuticular layer will closed with with DERMABOND GLUE
Device: DERMABOND GLUE
closing the intra-cuticular layer with Dermabond glue




Primary Outcome Measures :
  1. Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 2 month ]
    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


Secondary Outcome Measures :
  1. post operative complication [ Time Frame: 1 month ]
    Development of surgical site infection or wound disruption.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831946


Contacts
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Contact: Yair M Daykan, MD 972-542198231 yair.dykan@gmail.com
Contact: Reut Ohana 972-9-7471588 reut.ohana@clalit.org.il

Locations
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Israel
Meir Medical Center Recruiting
Kfar Saba,, Israel, 11125
Contact: Yair M Daykan, MD    972-54-2198231    yair.dykan@gmail.com   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Reut Ohana Meir Helsinki

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Responsible Party: Yair Daykan, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02831946    
Other Study ID Numbers: 0062-16-MMC
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: within 6 m of finishing the study
Keywords provided by Yair Daykan, Meir Medical Center:
skin closure
intracuticular suture
glue (dermabond)