Contact information
Type
Scientific
Primary contact
Dr Patorn Piromchai
ORCID ID
Contact details
Department of Otolaryngology
Faculty of Medicine
Khon Kaen University
Khon Kaen
40000
Thailand
+66 (081) 5444463
patorn@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00400465
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PDAT
Study hypothesis
Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.
We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.
Ethics approval
Approval was gained from the ethics committee of Khon Kaen University on the 22nd November 2006 (ref: HE491009).
Study design
Randomised single-blind controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Post-operative bleeding, haematoma
Intervention
After the thyroidectomy was performed, patients were randomised to one of the following groups:
1. Control group: pressure dressings
2. Experimental group: normal dressings
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Amount of fluids collected in the thyroid bed by ultrasonography
Secondary outcome measures
1. Days retained drains
2. Days of hospital stay
3. Complications (bruise, bleeding, wound dehiscence)
Overall trial start date
01/12/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing thyroidectomy in Srinagarind Hospital (Thailand)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
114
Participant exclusion criteria
1. Cervical lymph node metastases requiring neck dissection
2. Tissue pathology that showed anaplastic carcinoma
3. Clinical or laboratory indicators of coagulation disorders
Recruitment start date
01/12/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Thailand
Trial participating centre
Department of Otolaryngology
Khon Kaen
40000
Thailand
Sponsor information
Organisation
Khon Kaen University (Thailand)
Sponsor details
Faculty of Medicine
Mittrapharb Road
Khon Kaen
40000
Thailand
+66 (043) 348373
watcha_b@kku.ac.th
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Khon Kaen University (Thailand) - Faculty of Medicine (internally funded)
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