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Completed

NCT Number: NCT03120806

Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.

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

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Key information

Conditions

Cesarean Section Wound

Age range

19 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy medical school

Cairo, 12151, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interrupted subcuticular skin closure

Procedure

skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section

continuous subcuticular skin closure

Procedure

skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section

Primary outcomes

  1. wound infection

    Time frame: 10 days after surgery

    occurrence of signs of wound infection

Secondary outcomes

  1. scar dehiscence

    Time frame: 10 days after surgery

    occurrence of scar dehiscence or incisional hernia

  2. wound seroma

    Time frame: 10 days after surgery

    occurrence of seroma of wound

  3. the need for reclosure

    Time frame: 10 days after surgery

    actual gapping of wound

  4. postoperative pain

    Time frame: 12 hours after surgery

    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.

  5. wound hematoma

    Time frame: 10 days after surgery

    occurrence of subcutanous hematoma

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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