Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

Not Applicable

Completed

• Conditions: Caesarean Delivery
• Interventions: Procedure: subcutaneous adaption

• Registration Number: NCT01542346
• Lead Sponsor: Klinikum Klagenfurt am Wörthersee

Brief Summary

This is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-25
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-11
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

• women undergoing cesarean section for any indication
• literate in german language

Exclusion Criteria

• history of keloids
• previous transversal suprapubic scars
• known patient hypersensitivity to any of the suture materials used in the protocol
• a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wound closure with subcutaneous adaption	subcutaneous adaption	-

Primary Outcome Measures

Name	Time	Method
Objective and subjective cosmetic appearance	after 6 months

Secondary Outcome Measures

Name	Time	Method
Surgical site infection and wound breakdown	within 30 days after surgery
Haematoma	within 5 days after surgery

Trial Locations

Locations (1)

Klinikum Klagenfurt am Woerthersee; 🇦🇹 Klagenfurt, Carinthia, Austria