Is the routine Pressure Dressing After Thyroidectomy necessary? A prospective randomised controlled study

ISRCTN	ISRCTN52660978
DOI	https://doi.org/10.1186/ISRCTN52660978
ClinicalTrials.gov number	NCT00400465
Secondary identifying numbers	N/A

Submission date: 12/11/2006
Registration date: 13/12/2006
Last edited: 01/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Patorn Piromchai
Scientific

Department of Otolaryngology
Faculty of Medicine
Khon Kaen University
Khon Kaen
40000
Thailand

Phone	+66 (081) 5444463
Email	patorn@gmail.com

Study information

Study design	Randomised single-blind controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Is the routine Pressure Dressing After Thyroidectomy necessary? A prospective randomised controlled study
Study acronym	PDAT
Study objectives	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(s)	Approval was gained from the ethics committee of Khon Kaen University on the 22nd November 2006 (ref: HE491009).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2006
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	114
Key inclusion criteria	Patients undergoing thyroidectomy in Srinagarind Hospital (Thailand)
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Thailand

Study participating centre

Department of Otolaryngology

Khon Kaen
40000
Thailand

Sponsor information

Khon Kaen University (Thailand)
University/education

Faculty of Medicine
Mittrapharb Road
Khon Kaen
40000
Thailand

Phone	+66 (043) 348373
Email	watcha_b@kku.ac.th
Website	http://www.kku.ac.th/eng/
"ROR"	https://ror.org/03cq4gr50

Funders

Funder type

University/education

Khon Kaen University (Thailand) - Faculty of Medicine (internally funded)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/03/2008	01/02/2019	Yes	No

Editorial Notes

01/02/2019: Publication reference added