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

+66 (081) 5444463
patorn@gmail.com

Study information

Study designRandomised single-blind controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleIs the routine Pressure Dressing After Thyroidectomy necessary? A prospective randomised controlled study
Study acronymPDAT
Study objectivesThyroidectomy 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) studiedPost-operative bleeding, haematoma
InterventionAfter the thyroidectomy was performed, patients were randomised to one of the following groups:
1. Control group: pressure dressings
2. Experimental group: normal dressings
Intervention typeProcedure/Surgery
Primary outcome measureAmount of fluids collected in the thyroid bed by ultrasonography
Secondary outcome measures1. Days retained drains
2. Days of hospital stay
3. Complications (bruise, bleeding, wound dehiscence)
Overall study start date01/12/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants114
Key inclusion criteriaPatients undergoing thyroidectomy in Srinagarind Hospital (Thailand)
Key exclusion criteria1. 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 enrolment01/12/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Thailand

Study participating centre

Department of Otolaryngology
Khon Kaen
40000
Thailand

Sponsor information

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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