Skin and Fat Redundancy and Muscle DiastasesNCT00506740
Harmonic™ vs. Electrocautery in Abdominoplasties
A study testing Ultrasonic scalpel and monopolar electrosurgery generator and tip in people with Skin and Fat Redundancy and Muscle Diastases, run by Ethicon Endo-Surgery at 5 sites in 4 countries.
Trial summary
the objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in abdominolipectomy (tummy tuck)reduces volume and duration of wound drainage after surgery when compared to electrocautery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin and Fat Redundancy and Muscle Diastases
- What is being tested?
- Ultrasonic scalpel and monopolar electrosurgery generator and tip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Oct 2006to Jun 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects eligible for this clinical research study must fulfill all of the following criteria:
- Elected to undergo a full abdominoplasty procedure for aesthetics or post-obesity reasons
- Able to comprehend and sign the study informed consent form
- Able to return for all study mandated postoperative visits (3-4 days after the removal of drains, as well as 15 ± 2 days, and 30 ± 5 days after surgery); and
- Be greater than or equal to 18 years of age.
Who cannot join
- Subjects with any of the following criteria are not eligible to participate in this clinical research study:
- Current smoker
- Current use of steroids
- Diabetes Mellitus
- Need of lipocontouring, other than complementary liposuction of the flanks
- Need of a full body lift (belt lipectomy)
Show all 21Show fewer
- Need of concomitant surgical procedures via the abdominal flap (other than hernia repair, rectus plication, or liposuction of the flanks) or procedures in which the wound drainage would interconnect with the abdominal wound.
- Presence of ventral or umbilical hernia requiring repair with the use of prosthetic material (e.g., mesh)
- Morbid obesity (BMI ≥ 40)
- At risk for ischemia due to presence of obstruction of the arterial blood supply or inadequate blood flow
- Presence of midline scars that could limit flap advancement that are not limited to the infraumbilical region so they can be completely excised
- Right, left, or bilateral upper quadrant scars, (e.g., previous laparotomy via sub costal incision)
- Heart disease
- History of thromboembolic disease
- Current diagnosis or history of any disease that would impair healing process
- Current diagnosis or history of immune system disorders
- History of bleeding disorders
- Presence of uncontrolled hypertension
- Pregnant or lactating
- Being treated with anticoagulants including aspirin within 7 days prior to surgery (a washout period of 7 days will be required); or
- Participation in any other clinical studies.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45267-0558
Iowa City Plastic Surgery
Coralville, Iowa, 52241
Germany1 site
Abteilung für Plastische und Ästhetische Chirurgie
Wesseling, 50389
About this study
Official title: A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electrocautery in Abdominoplasties
the objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in abdominolipectomy (tummy tuck)reduces volume and duration of wound drainage after surgery when compared to electrocautery.
Read the detailed description
Abdominolipectomy is performed to correct abdominal skin and fat redundancy and muscle diastases. Persistent serous wound drainage and seromas are the most common complications in abdominolipectomy. The rate of serous fluid collection determines the time drains need to remain in place. Although suction drains reduce seroma formation, prolonged use can delay healing, cause injury, and increase the risk of retrograde infection and patient discomfort. Wound drainage has a direct correlation with seroma formation. The loss of protein nutrients and minerals in the serum drained is also a concern with prolonged drainage that can result in healing delays.
The Harmonic™ technology uses ultrasonic energy that allows both cutting and coagulating at the precise point of application. The Harmonic™ has been used since 1992 predominantly in urology and gastro-intestinal surgery (laparoscopic surgery). Significantly reduced serous drainage in a number of general surgery procedures such as superficial and total parotidectomy; thyroidectomy; tonsillectomy; pectoralis major myocutaneous flap dissection; axillary dissection; and lymphadenectomy have been reported with the use Harmonic™.
The Harmonic™ has also been used in parotidectomy and maxillofacial surgery, but its use has been seldom mentioned in the field of plastic and reconstructive surgery. Recent use of the Harmonic™ has shown promise in plastic and reconstructive surgery in dissection of the pectoralis major myocutaneous flap and total body lifts.
Comparisons: The Harmonic™ vs. electrocautery in abdominolipectomy.
- Being tested
- Ultrasonic scalpel, monopolar electrosurgery generator and tip
- Medical subject headings
- Diastasis, Muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic scalpelDevice
Also called 1) Sharp Curved Blade (HF105), 2) Generator (GEN04), 3) Hand Piece (HP054), Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.
A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
monopolar electrosurgery generator and tipDevice
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery | Active comparator | Elesurgical instruments are used to cut and coagulate tissue using alternatig electric current focusing intense heat at the surgical site. In electrosurgery, the patient is included in the circuit and current enters the patient's body. Receives: Device: Ultrasonic scalpel; Device: monopolar electrosurgery generator and tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume (mL) from the time of drain placement to time of drain removal.
Measured: from the time of drain placement to time of drain removal
Secondary outcomes (1)
Total number of hours from drain placement to drain removal
Measured: from drain placement to drain removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startOct 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin and Fat Redundancy and Muscle DiastasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Drik F Richter, M.D., Principal investigator, Leiter der Abteilung fuer Plastische Chirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506740
- Sponsor's protocol ID
- CI-06-0002
- Status last verified
- Aug 2015
- First submitted
- 24 Jul 2007
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electrocautery in Abdominoplasties
- ClinicalTrials.gov ID
- NCT00506740
- Acronym / sponsor ID
- CI-06-0002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Jul 2007 (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.
the objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in abdominolipectomy (tummy tuck)reduces volume and duration of wound drainage after surgery when compared to electrocautery.
Detailed description
Abdominolipectomy is performed to correct abdominal skin and fat redundancy and muscle diastases. Persistent serous wound drainage and seromas are the most common complications in abdominolipectomy. The rate of serous fluid collection determines the time drains need to remain in place. Although suction drains reduce seroma formation, prolonged use can delay healing, cause injury, and increase the risk of retrograde infection and patient discomfort. Wound drainage has a direct correlation with seroma formation. The loss of protein nutrients and minerals in the serum drained is also a concern with prolonged drainage that can result in healing delays.
The Harmonic™ technology uses ultrasonic energy that allows both cutting and coagulating at the precise point of application. The Harmonic™ has been used since 1992 predominantly in urology and gastro-intestinal surgery (laparoscopic surgery). Significantly reduced serous drainage in a number of general surgery procedures such as superficial and total parotidectomy; thyroidectomy; tonsillectomy; pectoralis major myocutaneous flap dissection; axillary dissection; and lymphadenectomy have been reported with the use Harmonic™.
The Harmonic™ has also been used in parotidectomy and maxillofacial surgery, but its use has been seldom mentioned in the field of plastic and reconstructive surgery. Recent use of the Harmonic™ has shown promise in plastic and reconstructive surgery in dissection of the pectoralis major myocutaneous flap and total body lifts.
Comparisons: The Harmonic™ vs. electrocautery in abdominolipectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrocautery | Active comparator | Device: Ultrasonic scalpel, Device: monopolar electrosurgery generator and tipElesurgical instruments are used to cut and coagulate tissue using alternatig electric current focusing intense heat at the surgical site. In electrosurgery, the patient is included in the circuit and current enters the patient's body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects eligible for this clinical research study must fulfill all of the following criteria:
- Elected to undergo a full abdominoplasty procedure for aesthetics or post-obesity reasons
- Able to comprehend and sign the study informed consent form
- Able to return for all study mandated postoperative visits (3-4 days after the removal of drains, as well as 15 ± 2 days, and 30 ± 5 days after surgery); and
- Be greater than or equal to 18 years of age.
Key exclusion criteria (21 listed)
- Subjects with any of the following criteria are not eligible to participate in this clinical research study:
- Current smoker
- Current use of steroids
- Diabetes Mellitus
- Need of lipocontouring, other than complementary liposuction of the flanks
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 |
|---|---|---|
| Ultrasonic scalpelAlso: 1) Sharp Curved Blade (HF105), 2) Generator (GEN04), 3) Hand Piece (HP054), Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application. | Device | Electrocautery |
| monopolar electrosurgery generator and tip | Device | Electrocautery |
Primary outcome
Total volume (mL) from the time of drain placement to time of drain removal.
Time frame: from the time of drain placement to time of drain removal
1 secondary outcome
Total number of hours from drain placement to drain removal
Time frame: from drain placement to drain removal
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 4 Aug 2015.
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.
Drik F Richter, M.D. principal investigator
Leiter der Abteilung fuer Plastische Chirurgie
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic scalpel and monopolar electrosurgery generator and tip in people with Skin and Fat Redundancy and Muscle Diastases, run by Ethicon Endo-Surgery at 5 sites in 4 countries.
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 5 inclusion and 21 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Argentina, Germany, Mexico. 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?
Total volume (mL) from the time of drain placement to time of drain removal. (time frame: from the time of drain placement to time of drain removal). 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 4 Aug 2015.