Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.

Study Overview
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Brief Summary
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Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the same suture material

Detailed Description
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Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who had their skin closed with subcuticular continous suture using the same suture material.

Official Title
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Comparative Study Between Interrupted and Continuous Subcuticular Skin Suturing in Women Undergoing Elective Cesarean Section. A Randomized Controlled Trial

Conditions
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Cesarean Section Wound

Intervention / Treatment
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* Procedure: Interrupted subcuticular skin closure
* Procedure: continuous subcuticular skin closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Overall good health Elective Cesarean section ASA class 1 or 2 Exclusion Criteria: Allergy to synthetic suture materials Diabetes whether gestational or pregestational use of steroid or immunosuppresive medication within last 6 month of procedure Skin sepsis or systemic fever BMI > 35 History of keloid or hypertrophic scar formation or dermatologic conditions known to impair wound healing ASA class 3 or 4

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continous subcuticular<br>skin closed with continous subcuticular mattress suture using non-absorbable polypropylene | Procedure: continuous subcuticular skin closure<br>* skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section<br>|
| Active Comparator: Interrupted subcuticular<br>skin closed with interrupted subcuticular mattress suture using non-absorbable polypropylene | Procedure: Interrupted subcuticular skin closure<br>* skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection | occurrence of signs of wound infection | 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar dehiscence | occurrence of scar dehiscence or incisional hernia | 10 days after surgery | 
| wound seroma | occurrence of seroma of wound | 10 days after surgery | 
| the need for reclosure | actual gapping of wound | 10 days after surgery | 
| postoperative pain | through visual analogue score The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. | 12 hours after surgery | 
| wound hematoma | occurrence of subcutanous hematoma | 10 days after surgery |