Subcutaneous Adaption and Cosmetic Outcome Following Caes... | NCT01542346

Studies
Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

NCT01542346

Sponsor

Klinikum Klagenfurt am Wörthersee

Status

Completed

Last Update Posted

Jul 15, 2013Estimated

Enrollment

116Estimated

Phase

Not Applicable

Conditions

Caesarean Delivery

Interventions

subcutaneous adaption

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 25, 2012

First Submission Date that Met QC Criteria

Mar 1, 2012

First Posted Date

Mar 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2013

Last Update Posted Date

Jul 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Husslein Heinrich, MD, Principal investigator, Klinikum Klagenfurt am WörtherseePrincipal Investigator

Lead Sponsor

Klinikum Klagenfurt am WörtherseeOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
wound closure with subcutaneous adaption	Experimental		Procedure: subcutaneous adaption

Interventions

Name	Type	Description	Arm Group Labels	Other Names
subcutaneous adaption	Procedure		wound closure with subcutaneous adaption

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective and subjective cosmetic appearance		after 6 months

Secondary Outcomes

Measure	Description	Time Frame
Surgical site infection and wound breakdown		within 30 days after surgery
Haematoma		within 5 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heinrich Husslein, M.D.	Klinikum Klagenfurt am Woerthersee and Medical University Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Klagenfurt am Woerthersee		Klagenfurt	Carinthia	9020	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25494177	Derived	Husslein H, Gutschi M, Leipold H, Herbst C, Franz M, Worda C. Suture Closure versus Non-Closure of Subcutaneous Fat and Cosmetic Outcome after Cesarean Section: A Randomized Controlled Trial. PLoS One. 2014 Dec 10;9(12):e114730. doi: 10.1371/journal.pone.0114730. eCollection 2014.