Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee
ClinicalTrials.gov Identifier:
NCT01542346
First received: February 25, 2012
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Caesarean Delivery
Procedure: subcutaneous adaption

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

Resource links provided by NLM:


Further study details as provided by Klinikum Klagenfurt am Wörthersee:

Primary Outcome Measures:
  • Objective and subjective cosmetic appearance [ Time Frame: after 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical site infection and wound breakdown [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: No ]
  • Haematoma [ Time Frame: within 5 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: March 2012
Arms Assigned Interventions
Experimental: wound closure with subcutaneous adaption Procedure: subcutaneous adaption

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542346

Locations
Austria
Klinikum Klagenfurt am Woerthersee
Klagenfurt, Carinthia, Austria, 9020
Sponsors and Collaborators
Klinikum Klagenfurt am Wörthersee
Investigators
Principal Investigator: Heinrich Husslein, M.D. Klinikum Klagenfurt am Woerthersee and Medical University Vienna
  More Information

No publications provided

Responsible Party: Husslein Heinrich, MD, Principal investigator, Klinikum Klagenfurt am Wörthersee
ClinicalTrials.gov Identifier: NCT01542346     History of Changes
Other Study ID Numbers: A 16/11
Study First Received: February 25, 2012
Last Updated: July 11, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Klinikum Klagenfurt am Wörthersee:
Wound closure
cosmetic outcome

ClinicalTrials.gov processed this record on April 20, 2014