Harmonic vs HF Knife in Patients Requiring Abdominal Surgery

April 5, 2018 updated by: Asklepios proresearch

Clinical Outcome of the Seroma Amount Using the Harmonic vs the HF Knife for Surgery According to Lockwood and Abdominoplastic Surgery: A Prospective Controlled Study

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22043
        • Asklepios Klinik Wandsbek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Harmonic knife
surgery using the Harmonic knife
Procedure: abdominal plastic surgery
Surgery for ABDOMINAL SUBCUTANEOUS FAT
Active Comparator: HF knife
Procedure: abdominal plastic surgery
Surgery for ABDOMINAL SUBCUTANEOUS FAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of seroma
Time Frame: first post operative day until hospital discharge
first post operative day until hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios proresearch

Collaborators

Ethicon Endo-Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (Estimate)

December 17, 2010

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

December 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • ASK # 1557
  • 2909 (Other Identifier: Ethics committee der Aerztekammer Hamburg)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ABDOMINAL SUBCUTANEOUS FAT

Clinical Trials on abdominal plastic surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe