Harmonic vs HF Knife in Patients Requiring Abdominal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Asklepios proresearch.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT01262378
First received: December 16, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 ] [ Designated as safety issue: No ]

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
Surgery for ABDOMINAL SUBCUTANEOUS FAT
Active Comparator: HF knife Procedure: abdominal plastic surgery
Surgery for ABDOMINAL SUBCUTANEOUS FAT

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262378

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

No publications provided

Responsible Party: Dr. Klaus Mueller, Asklepios Klinik Wandsbek
ClinicalTrials.gov Identifier: NCT01262378     History of Changes
Other Study ID Numbers: ASK # 1557, 2909
Study First Received: December 16, 2010
Last Updated: December 16, 2010
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on October 29, 2014