Harmonic vs HF Knife in Patients Requiring Abdominal Surgery

NCT ID: NCT01262378

Last Updated: 2018-04-06

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-11-30

Brief Summary

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Prospective, non-randomized, controlled study to investigate the clinical outcome of surgery using the Harmonic knife vs the HF knife in patients requiring abdominoplastic surgery or body lift (Lockwood)

Detailed Description

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Aim of the study is to measure amount of seroma in each interventional arm.

Conditions

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ABDOMINAL SUBCUTANEOUS FAT

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Harmonic knife

surgery using the Harmonic knife

Group Type OTHER

abdominal plastic surgery

Intervention Type PROCEDURE

Surgery for ABDOMINAL SUBCUTANEOUS FAT

HF knife

Group Type ACTIVE_COMPARATOR

abdominal plastic surgery

Intervention Type PROCEDURE

Surgery for ABDOMINAL SUBCUTANEOUS FAT

Interventions

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abdominal plastic surgery

Surgery for ABDOMINAL SUBCUTANEOUS FAT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years
* willing to give consent
* indication for abdominoplastic surgery
* no contraindication for general anaesthesia

Exclusion Criteria

* Smoking more than 10 p/day
* Diabetes mellitus I or II
* known neoplasms
* not willing or able to conform with study requirements
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role collaborator

Asklepios proresearch

INDUSTRY

Sponsor Role lead

Responsible Party

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Asklepios Klinik Wandsbek

Locations

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Asklepios Klinik Wandsbek

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2909

Identifier Type: OTHER

Identifier Source: secondary_id

ASK # 1557

Identifier Type: -

Identifier Source: org_study_id

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