Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P0505
Study information
Scientific title
A study of power Doppler harmonic imaging in the monitoring of human free-flap tissue perfusion
Acronym
Study hypothesis
Contrast harmonic imaging is a superior monitoring method for free flaps compared to standard monitoring.
Ethics approval
Dorset Research Ethics Committee, approved on 04/05/2005 (ref: 05/Q2201/27)
Study design
Interventional single-arm open crossover pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Free flap reconstruction for head and neck cancer patients
Intervention
Each participant was monitored by both standard procedures and Power Doppler, as follows:
Power Doppler contrast enhanced harmonic imaging was carried out at 12, 24 and 48 hours post-surgery.
Standard monitoring consisted of the following: clinical observation and hand-held non-imaging spectral Doppler (NISD). Standard monitoring was performed for 14 days par participant.
Intervention type
Procedure/Surgery
Phase
Phase IV
Drug names
Primary outcome measure
1. Qualitative and quantitative analysis of harmonic imaging at 12, 24 and 48 hours post-surgery
2. Time taken for detection of flap failure compared to standard monitoring within 48 hours post-surgery
Secondary outcome measures
No secondary outcome measures
Overall trial start date
19/05/2005
Overall trial end date
19/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (both males and females) undergoing head and neck surgery requiring free tissue transfer.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36
Participant exclusion criteria
1. Patients under 18 years
2. Pregnancy and lactation
3. Hypersensitivity to SonoVue®
4. Recent coronary syndrome
5. Ischaemic heart disease
6. Cardiovascular compromise
Recruitment start date
19/05/2005
Recruitment end date
19/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Maxillofacial Surgery
Poole
BH15 2JB
United Kingdom
Sponsor information
Organisation
Poole Hospital NHS Foundation Trust (UK)
Sponsor details
Longfleet Road
Poole
BH15 2JB
United Kingdom
mary.burrows@poole.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Association of Oral and Maxillofacial Surgeons (BAOMS) (UK) - clinical research grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20832244
Publication citations
-
Results
Sharma S, Anand R, Hickman M, Senior R, Walji S, Ramchandani PL, Culliford D, Ilankovan V, Greaves K, Power modulation contrast enhanced ultrasound for postoperative perfusion monitoring following free tissue transfer in head and neck surgery., Int J Oral Maxillofac Surg, 2010, 39, 12, 1211-1217, doi: 10.1016/j.ijom.2010.07.013.