Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

Study Overview
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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.

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

Conditions
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Adhesive; Band, Suture; Complications

Intervention / Treatment
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* Device: MODIFIED VICRYL PLUS
* Device: DERMABOND GLUE


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MODIFIED VICRYL PLUS<br>The intra-cuticular layer will closed with with VICRYL PLUS suture | Device: MODIFIED VICRYL PLUS<br>* closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture<br>|
| Experimental: DERMABOND GLUE<br>The intra-cuticular layer will closed with with DERMABOND GLUE | Device: DERMABOND GLUE<br>* closing the intra-cuticular layer with Dermabond glue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin closure, intracuticular suture, glue (dermabond)