Harmonic vs HF Knife in Patients Requiring Abdominal Surgery | NCT01262378

Studies
Harmonic vs HF Knife in Patients Requiring Abdominal Surgery

NCT01262378

Sponsor

Asklepios proresearch

Status

Completed

Last Update Posted

Apr 6, 2018Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

ABDOMINAL SUBCUTANEOUS FAT

Interventions

abdominal plastic surgery

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2909	Other Identifier	Ethics committee der Aerztekammer Hamburg

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Dec 16, 2010

First Submission Date that Met QC Criteria

Dec 16, 2010

First Posted Date

Dec 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2018

Last Update Posted Date

Apr 6, 2018Actual

Name	Class
Ethicon Endo-Surgery	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Harmonic knife	Other	surgery using the Harmonic knife	Procedure: abdominal plastic surgery
HF knife	Active Comparator		Procedure: abdominal plastic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
abdominal plastic surgery	Procedure	Surgery for ABDOMINAL SUBCUTANEOUS FAT	HF knife Harmonic knife

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asklepios Klinik Wandsbek		Hamburg		22043	Germany