Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.

Cesarean Section Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120806
• Other study ID #: 167
• Status: Completed
• Phase: N/A
• Start date: April 16, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 20, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Wound

Intervention

Procedure:
• Interrupted subcuticular skin closure
skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section
• continuous subcuticular skin closure
skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound infection	occurrence of signs of wound infection	10 days after surgery
Secondary	scar dehiscence	occurrence of scar dehiscence or incisional hernia	10 days after surgery
Secondary	wound seroma	occurrence of seroma of wound	10 days after surgery
Secondary	the need for reclosure	actual gapping of wound	10 days after surgery
Secondary	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
Secondary	wound hematoma	occurrence of subcutanous hematoma	10 days after surgery