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

Not Applicable

Withdrawn

• Conditions: Breast Reconstruction
• Interventions: Procedure: Electrocautery Diathermy; Procedure: Harmonic Synergy Dissecting Hook (Harmonic Scalpel)

• Registration Number: NCT00778947
• Lead Sponsor: St Andrew's Centre for Plastic Surgery

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-24
• Study Start: 2008-11
• Primary Completion: 2009-09
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Electrocautery Diathermy	-
1	Harmonic Synergy Dissecting Hook (Harmonic Scalpel)	-

Primary Outcome Measures

Name	Time	Method
The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient.	At surgery

Secondary Outcome Measures

Name	Time	Method
Return to theatre	post operation for 6 months
Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire	At surgery
Post operative pain, based on the visual analogue scale at 3, 6, 12 and 24 weeks post operatively.	3, 6, 12 and 24 weeks post operation
Rates of post operative infection	post operation for 6 months
Incidence of abdominal (donor site) wound dehiscence	post operation for 6 months
Bleeding complications	intra operation and for 6 months post op
Post operative drainage from the wound	post operation for 6 months
Incidence of seroma	post operation for 6 months
Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively	3, 6, 12, and 24 weeks post operation
Number of days of hospitalisation	post operation for 6 months
Re-operation required	post operation for 6 months

Trial Locations

Locations (1)

St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,; 🇬🇧 Chelmsford, United Kingdom