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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014