Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

Caesarean Delivery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542346
• Other study ID #: A 16/11
• Status: Completed
• Phase: N/A
• First received: February 25, 2012
• Last updated: July 11, 2013
• Start date: March 2012

Study information

• Verified date: July 2013
• Source: Klinikum Klagenfurt am Wörthersee
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caesarean Delivery

Intervention

Procedure:
• subcutaneous adaption

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Woerthersee	Klagenfurt	Carinthia

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Klagenfurt am Wörthersee

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective and subjective cosmetic appearance		after 6 months	No
Secondary	Surgical site infection and wound breakdown		within 30 days after surgery	No
Secondary	Haematoma		within 5 days after surgery	No