Condition category
Surgery
Date applied
31/12/2008
Date assigned
13/02/2009
Last edited
17/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sanjay Sharma

ORCID ID

Contact details

Department of Maxillofacial Surgery
Poole Hospital
Longfleet Road
Dorset
Poole
BH15 2JB
United Kingdom

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 measures

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

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

http://www.poole.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20832244

Publication citations

  1. 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.

Additional files

Editorial Notes