NCT01542346

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

First QC Date

February 25, 2012

Last Update Submit

July 11, 2013

Conditions

Caesarean Delivery

Keywords

Wound closurecosmetic outcome

Outcome Measures

Primary Outcomes (1)

  • Objective and subjective cosmetic appearance

    after 6 months

Secondary Outcomes (2)

  • Surgical site infection and wound breakdown

    within 30 days after surgery

  • Haematoma

    within 5 days after surgery

Study Arms (1)

wound closure with subcutaneous adaption

EXPERIMENTAL
Procedure: subcutaneous adaption

Interventions

subcutaneous adaptionPROCEDURE
wound closure with subcutaneous adaption

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women undergoing cesarean section for any indication
  • literate in german language

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Klagenfurt am Woerthersee

Klagenfurt, Carinthia, 9020, Austria

Location

Related Publications (1)

  • 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.

    PMID: 25494177DERIVED

Study Officials

  • Heinrich Husslein, M.D.

    Klinikum Klagenfurt am Woerthersee and Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 25, 2012

First Posted

March 2, 2012

Study Start

March 1, 2012

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

AU(1)