Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542346
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : July 15, 2013
Information provided by (Responsible Party):
Husslein Heinrich, MD, 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.

Condition or disease Intervention/treatment Phase
Caesarean Delivery Procedure: subcutaneous adaption Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: wound closure with subcutaneous adaption Procedure: subcutaneous adaption

Primary Outcome Measures :
  1. Objective and subjective cosmetic appearance [ Time Frame: after 6 months ]

Secondary Outcome Measures :
  1. Surgical site infection and wound breakdown [ Time Frame: within 30 days after surgery ]
  2. Haematoma [ Time Frame: within 5 days after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01542346

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Husslein Heinrich, MD, Principal investigator, Klinikum Klagenfurt am Wörthersee Identifier: NCT01542346     History of Changes
Other Study ID Numbers: A 16/11
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Keywords provided by Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee:
Wound closure
cosmetic outcome