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Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02831946
Acronym
SVGCS
Enrollment
100
Registered
2016-07-13
Start date
2016-05-31
Completion date
2018-02-28
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive; Band, Suture; Complications

Keywords

skin closure, intracuticular suture, glue (dermabond)

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.

Interventions

DEVICEMODIFIED VICRYL PLUS

closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture

DEVICEDERMABOND GLUE

closing the intra-cuticular layer with Dermabond glue

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient and Observer Scar Assessment Scale (POSAS)2 monthSubjective 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

MeasureTime frameDescription
post operative complication1 monthDevelopment of surgical site infection or wound disruption.

Countries

Israel

Contacts

Primary ContactYair M Daykan, MD
yair.dykan@gmail.com972-542198231
Backup ContactReut Ohana
reut.ohana@clalit.org.il972-9-7471588

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026