NCT01262378

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
Last Updated

April 6, 2018

Status Verified

December 1, 2010

Enrollment Period

1.7 years

First QC Date

December 16, 2010

Last Update Submit

April 5, 2018

Conditions

ABDOMINAL SUBCUTANEOUS FAT

Outcome Measures

Primary Outcomes (1)

  • amount of seroma

    first post operative day until hospital discharge

Study Arms (2)

Harmonic knife

OTHER

surgery using the Harmonic knife

Procedure: abdominal plastic surgery

HF knife

ACTIVE COMPARATOR
Procedure: abdominal plastic surgery

Interventions

abdominal plastic surgeryPROCEDURE

Surgery for ABDOMINAL SUBCUTANEOUS FAT

HF knifeHarmonic knife

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepios Klinik Wandsbek

Hamburg, 22043, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 17, 2010

Study Start

February 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

April 6, 2018

Record last verified: 2010-12

Locations

DE(1)