Contact information
Type
Scientific
Primary contact
Prof Valerie J Lund
ORCID ID
Contact details
Department of ENT
RNTNE
Royal Free Hampstead NHS Trust
330 Grays Inn Road
King's Cross
London
WC1X 8DA
United Kingdom
+44 (0)20 7915 1300
v.lund@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256159712
Study information
Scientific title
Acronym
Study hypothesis
The study aims to evaluate the effects of mitomycin C on wound healing, its effects in the prevention of the formation of adhesions as well as preventing restenosis.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Endoscopic sinus surgery (ESS)
Intervention
Patients undergoing ESS to the frontonasal recess for chronic rhinosinusitis are randomly allocated to receive either MMC or placebo solution applied to the frontonasal recess.
Intervention type
Drug
Phase
Not Specified
Drug names
mitomycin C
Primary outcome measures
1. Patency of the frontonasal recess.
2. Study of the formation of adhesions and rate of restenosis post operatively.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2005
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2005
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of ENT, RNTNE
London
WC1X 8DA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Free Hampstead NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Professorial Unit RNTNE
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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
2006 results of pilot study on http://www.ncbi.nlm.nih.gov/pubmed/17181099
Publication citations
-
Results of pilot study
Amonoo-Kuofi K, Lund VJ, Andrews P, Howard DJ, The role of mitomycin C in surgery of the frontonasal recess: a prospective open pilot study., Am J Rhinol, 20, 6, 591-594.