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Harmonic vs HF Knife in Patients Requiring Abdominal Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Asklepios proresearch.
Recruitment status was:  Active, not recruiting
Ethicon Endo-Surgery
Information provided by:
Asklepios proresearch Identifier:
First received: December 16, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
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 Intervention
Abdominal Subcutaneous Fat
Procedure: abdominal plastic surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Asklepios proresearch:

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

Enrollment: 22
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Harmonic knife
surgery using the Harmonic knife
Procedure: abdominal plastic surgery
Active Comparator: HF knife Procedure: abdominal plastic surgery

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

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

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
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Please refer to this study by its identifier: NCT01262378

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

Responsible Party: Dr. Klaus Mueller, Asklepios Klinik Wandsbek Identifier: NCT01262378     History of Changes
Other Study ID Numbers: ASK # 1557
2909 ( Other Identifier: Ethics committee der Aerztekammer Hamburg )
Study First Received: December 16, 2010
Last Updated: December 16, 2010 processed this record on May 25, 2017