Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

NCT ID: NCT01542346

Last Updated: 2013-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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

Detailed Description

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Conditions

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Caesarean Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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wound closure with subcutaneous adaption

Group Type EXPERIMENTAL

subcutaneous adaption

Intervention Type PROCEDURE

Interventions

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subcutaneous adaption

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Klinikum Klagenfurt am Wörthersee

OTHER

Sponsor Role lead

Responsible Party

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Husslein Heinrich, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heinrich Husslein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Klagenfurt am Woerthersee and Medical University Vienna

Locations

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Klinikum Klagenfurt am Woerthersee

Klagenfurt, Carinthia, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 25494177 (View on PubMed)

Other Identifiers

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A 16/11

Identifier Type: -

Identifier Source: org_study_id

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