Suture Versus Glue (Dermabond) Closure During Cesarean Delivery (SVGCS)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Adhesive; Band Suture; Complications||Device: MODIFIED VICRYL PLUS Device: DERMABOND GLUE||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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
- post operative complication [ Time Frame: 1 month ]Development of surgical site infection or wound disruption.
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
|Contact: Yair M Daykan, MDemail@example.com|
|Contact: Reut Ohanafirstname.lastname@example.org|
|Meir Medical Center||Recruiting|
|Kfar Saba,, Israel, 11125|
|Contact: Yair M Daykan, MD 972-54-2198231 email@example.com|
|Principal Investigator:||Reut Ohana||Meir Helsinki|