Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction (HARMONIC001)

St Andrew's Centre for Plastic Surgery

Status: Withdrawn

Conditions: Breast Reconstruction

Treatments: Procedure: Electrocautery Diathermy; Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)

Study type: Interventional

Funder types: Other

Identifiers

NCT00778947

Harmonic Scalpel HARMONIC 001

Details and patient eligibility

About

The purpose of this single centre study is to evaluate whether the use of Harmonic Synergy Dissecting Hook (Harmonic Scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time taken to return to daily activities.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients aged between 18 and 80 years old
2. Able to comprehend, follow, and provide written informed consent.
3. Willingness to comply with study requirements including follow-up visits

Exclusion criteria

1. Patients who have a pacemaker
2. Pregnant or breast feeding females.
3. General contraindication for surgery as deemed by the PI (e.g. physically unfit)
4. Patients who smoke
5. Diabetic patients
6. Patients who are receiving permanent analgesics
7. Patients receiving anti-coagulation therapy.
8. Patients with a physical or psychological condition which would impair participation in the study.
9. Participation in any other device or drug study within 90 days prior to enrollment.
10. Planned participation in any other medical device study during the timeframe of this study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

1

Active Comparator group

Treatment:

Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)

2

Active Comparator group

Treatment:

Procedure: Electrocautery Diathermy