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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00778947
Other study ID # Harmonic Scalpel HARMONIC 001
Secondary ID
Status Withdrawn
Phase N/A
First received October 22, 2008
Last updated May 16, 2016
Start date November 2008

Study information

Verified date October 2008
Source St Andrew's Centre for Plastic Surgery
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
Harmonic Synergy Dissecting Hook (Harmonic Scalpel)
Harmonic Synergy Dissecting Hook (Harmonic Scalpel) uses ultrasound waves to coagulate and cut in surgery. It is available on the market, holds a CE mark and is coded as a Class IIb medical device.
Electrocautery Diathermy
Electrosurgery uses high temperatures (150-400oC) and causes obliterative coagulation. Diathermy is the use of high frequency electric current to produce heat. In surgery it is used to cut or destroy tissue and/or to produce coagulation. The electrical frequency produced in diathermy is in the range of 300kHz to 3MHz.

Locations

Country Name City State
United Kingdom St. Andrew's Centre for Plastic Surgery, Broomfield Hospital, Chelmsford

Sponsors (1)

Lead Sponsor Collaborator
St Andrew's Centre for Plastic Surgery

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The speed of flap harvest measured as the time from "knife to skin" to the flap being removed from the patient. At surgery No
Secondary Ease of flap harvest: the subjective opinion of the surgeon based on structured questionnaire At surgery No
Secondary 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 Yes
Secondary Rates of post operative infection post operation for 6 months Yes
Secondary Incidence of abdominal (donor site) wound dehiscence post operation for 6 months Yes
Secondary Bleeding complications intra operation and for 6 months post op Yes
Secondary Return to theatre post operation for 6 months Yes
Secondary Incidence of seroma post operation for 6 months Yes
Secondary Post operative drainage from the wound post operation for 6 months Yes
Secondary Impact on daily activities (SF-36 Questionnaire) at 3, 6, 12 and 24 weeks post operatively 3, 6, 12, and 24 weeks post operation Yes
Secondary Number of days of hospitalisation post operation for 6 months Yes
Secondary Re-operation required post operation for 6 months Yes
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