Status:
WITHDRAWN
Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction
Lead Sponsor:
St Andrew's Centre for Plastic Surgery
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Female patients aged between 18 and 80 years old
- Able to comprehend, follow, and provide written informed consent.
- Willingness to comply with study requirements including follow-up visits
Exclusion
- Patients who have a pacemaker
- Pregnant or breast feeding females.
- General contraindication for surgery as deemed by the PI (e.g. physically unfit)
- Patients who smoke
- Diabetic patients
- Patients who are receiving permanent analgesics
- Patients receiving anti-coagulation therapy.
- Patients with a physical or psychological condition which would impair participation in the study.
- Participation in any other device or drug study within 90 days prior to enrollment.
- Planned participation in any other medical device study during the timeframe of this study.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00778947
Start Date
November 1 2008
Last Update
May 17 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Andrew's Centre for Plastic Surgery, Broomfield Hospital,
Chelmsford, United Kingdom