Enhancing dermatological diagnoses in patients with skin diseases at the National Institute for Infectious and Tropical Diseases in Hanoi

ISRCTN	ISRCTN17146141
DOI	https://doi.org/10.1186/ISRCTN17146141
Secondary identifying numbers	ctu01dtfec08

Submission date: 16/07/2008
Registration date: 17/07/2008
Last edited: 16/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Walter Bob Taylor
Scientific

The Oxford University Clinical Research Unit (OUCRU)
National Institute of Infectious and Tropical Diseases (NIITD)
78 Giai Phong Street
Hanoi
-
Viet Nam

Phone	+84 4 576 4320
Email	btaylor@oucru.org

Study information

Study design	This is a pilot study without a formal sample size calculation.
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	The rationale of this protocol is to begin the first steps of skin research at National Institute for Infectious and Tropical Diseases in Hanoi.
Ethics approval(s)	Ethics approval received from the Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK) on the 20th June 2008 (ref: 12/08). Ethics approval pending as of 16/07/2008 from the ethics committee of the National Institute of Infectious and Tropical Diseases (NIITD).
Health condition(s) or problem(s) studied	Dermatology/skin rashes
Intervention	This pilot study is not randomised or controlled. Potential study participants will be patients with a rash of unknown cause of with a suspected rash of one of the diseases of interest. For the patients in whom a skin biopsy is thought to be clinically important, a discussion will first take place between the research team and the treating physicians. If it is decided that a skin biopsy is indicated, the patient will be told about the study and, if interested, a member of the research team will go through the informed consent process. Skin biopsies will be divided and placed in suitable media for further investigation. This will include: 1. 10% buffered formalin for routine histology and polymerase chain reaction (PCR) 2. Michel's solution for immunoflourescence 3. Viral transport medium for viral culture 4. Sterile container for bacterial or fungal culture 5. Glutaldehyde for electron microscopy If a skin scraping is done, it will be sent for microscopy (KOH stain) and/or fungal culture. Fluid from vesicles may be sent to the laboratory for herpes PCR. Basic clinical history history, past medical history, drug history, previous skin diseases, physical examination, including the skin rash distribution, and the results of routine investigations will also be performed.
Intervention type	Other
Primary outcome measure	Clinical diagnosis
Secondary outcome measures	No secondary outcome measures
Overall study start date	31/07/2008
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	100 patients
Key inclusion criteria	1. Patients admitted to the NIITD of any age, either sex 2. Obtaining informed consent 3. Any patient with an undiagnosed rash 4. Any patient with suspected Streptococcus suis, Penicillium marneffei, typhus or dengue
Key exclusion criteria	An active bleeding tendency
Date of first enrolment	31/07/2008
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

Viet Nam

Study participating centre

The Oxford University Clinical Research Unit (OUCRU)

Hanoi
-
Viet Nam

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom

Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 077078)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan