NCT00506740

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable

Geographic Reach
4 countries

5 active sites

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

October 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

First QC Date

July 24, 2007

Last Update Submit

August 3, 2015

Conditions

Skin and Fat Redundancy and Muscle Diastases

Outcome Measures

Primary Outcomes (1)

  • Total volume (mL) from the time of drain placement to time of drain removal.

    from the time of drain placement to time of drain removal

Secondary Outcomes (1)

  • Total number of hours from drain placement to drain removal

    from drain placement to drain removal

Study Arms (1)

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.

Device: Ultrasonic scalpelDevice: monopolar electrosurgery generator and tip

Interventions

Ultrasonic scalpelDEVICE

A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.

Also known as: 1) Sharp Curved Blade (HF105), 2) Generator (GEN04), 3) Hand Piece (HP054), Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.
Electrocautery
monopolar electrosurgery generator and tipDEVICE
Electrocautery

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Iowa City Plastic Surgery

Coralville, Iowa, 52241, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0558, United States

Location

Centro Zimman de Cirugia Plastica

Buenos Aires, C1425BBE, Argentina

Location

Abteilung für Plastische und Ästhetische Chirurgie

Wesseling, 50389, Germany

Location

Centro Medico Dalinde

Mexico City, 06760, Mexico

Location

MeSH Terms

Conditions

Diastasis, Muscle

Interventions

Radionuclide Generators

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Radiation Equipment and SuppliesEquipment and Supplies

Study Officials

  • Drik F Richter, M.D.

    Leiter der Abteilung fuer Plastische Chirurgie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 25, 2007

Study Start

October 1, 2006

Study Completion

June 1, 2007

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

US(2)DE(1)AR(1)ME(1)