Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

NCT00819260 | Terminated Results

• 1 other identifier: 1182DF9
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery. The three metrics are:

1. 1.the time taken to complete the operation
2. 2.drainage volume in the days immediately following surgery,
3. 3.patient pain in the days immediately following surgery.

Conditions

Hyperplasia

Keywords

Mammaplasty; Electrocoagulation; Breast

Outcome Measures

Primary Outcomes (1)

• Time for Operation

  Time to complete the breast reduction per breast.

  day of surgery

Secondary Outcomes (3)

• Volume of Drainage in Surgical Drains

  within one week of surgery

• Pain Level in Surgical Sites

  first week after surgery

• Hematoma

  first day after surgery

Study Arms (2)

Harmonic Reduced Breast

EXPERIMENTAL

harmonic scalpel used to reduce breast on that side

Device: Harmonic Scalpel

Electrocautery Reduced Breast

ACTIVE COMPARATOR

Electrocautery (current practice = control) used to reduce breast on that side

Device: Electrocautery

Interventions

Harmonic Scalpel DEVICE

harmonic scalpel used to reduce breast on this side

Harmonic Reduced Breast

Electrocautery DEVICE

Electrocautery used to reduce breast on this side

Electrocautery Reduced Breast

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.

You may not qualify if:

• under 18 years of age

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Ethicon Endo-Surgery: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Hyperplasia; Hyperthermia

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

We made a first analysis after 26 (intended enrollment 50) patients were enrolled and a result was strongly suggested. While the analysis was refined, 5 more patients enrolled. The study was then stopped after 31 patients enrolled.

Results Point of Contact

• Title: Carolyn L. Kerrigan MD
• Organization: Dartmouth-Hitchcock

carolyn.kerrigan@hitchcock.org

603-650-5148

Study Officials

• Carolyn L Kerrigan, MD

  DHMC

  PRINCIPAL INVESTIGATOR

• Todd E Burdette, MD

  DHMC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 20, 2013
• Results First Posted: May 20, 2013

Record last verified: 2013-05

Locations

US (1)