ABDOMINAL SUBCUTANEOUS FATNCT01262378
Harmonic vs HF Knife in Patients Requiring Abdominal Surgery
A study testing abdominal plastic surgery in people with ABDOMINAL SUBCUTANEOUS FAT, run by Asklepios proresearch at 1 site in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ABDOMINAL SUBCUTANEOUS FAT
- What is being tested?
- abdominal plastic surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years
- willing to give consent
- indication for abdominoplastic surgery
- no contraindication for general anaesthesia
Who cannot join
- Smoking more than 10 p/day
- Diabetes mellitus I or II
- known neoplasms
- not willing or able to conform with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the detailed description
Aim of the study is to measure amount of seroma in each interventional arm.
- Conditions
- ABDOMINAL SUBCUTANEOUS FAT
- Being tested
- abdominal plastic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal plastic surgeryProcedure or surgery
Surgery for ABDOMINAL SUBCUTANEOUS FAT
| Study group | Role | What they receive |
|---|---|---|
| Harmonic knife | Other | surgery using the Harmonic knife Receives: Procedure: abdominal plastic surgery |
| HF knife | Active comparator | Not described Receives: Procedure: abdominal plastic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of seroma
Measured: first post operative day until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ABDOMINAL SUBCUTANEOUS FATStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ethicon Endo-Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262378
- Sponsor's protocol ID
- ASK # 1557
- Other IDs
- 2909
- Status last verified
- Dec 2010
- First submitted
- 16 Dec 2010
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01262378
- Acronym / sponsor ID
- ASK # 1557
- Conditions
- ABDOMINAL SUBCUTANEOUS FAT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmonic knife | Other | Procedure: abdominal plastic surgerysurgery using the Harmonic knife |
| HF knife | Active comparator | Procedure: abdominal plastic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years
- willing to give consent
- indication for abdominoplastic surgery
- no contraindication for general anaesthesia
Key exclusion criteria (4 listed)
- Smoking more than 10 p/day
- Diabetes mellitus I or II
- known neoplasms
- not willing or able to conform with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal plastic surgerySurgery for ABDOMINAL SUBCUTANEOUS FAT | Procedure or surgery | HF knife, Harmonic knife |
Primary outcome
amount of seroma
Time frame: first post operative day until hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal plastic surgery in people with ABDOMINAL SUBCUTANEOUS FAT, run by Asklepios proresearch at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of seroma (time frame: first post operative day until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.