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Harmonic vs HF Knife in Patients Requiring Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT01262378
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Asklepios proresearch

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
ABDOMINAL SUBCUTANEOUS FAT Procedure: abdominal plastic surgery Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. amount of seroma [ Time Frame: first post operative day until hospital discharge ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262378


Locations
Germany
Asklepios Klinik Wandsbek
Hamburg, Germany, 22043
Sponsors and Collaborators
Asklepios proresearch
Ethicon Endo-Surgery

Responsible Party: Dr. Klaus Mueller, Asklepios Klinik Wandsbek
ClinicalTrials.gov Identifier: NCT01262378     History of Changes
Other Study ID Numbers: ASK # 1557
2909 ( Other Identifier: Ethics committee der Aerztekammer Hamburg )
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: December 2010