Is the Routine Pressure Dressing After Thyroidectomy Necessary?

March 31, 2015 updated by: Patorn Piromchai, Khon Kaen University

Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thyroidectomy is an operation that is commonly performed. In Department of Otolaryngology, Khonkaen University was performed this operation about 200 cases per years. 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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Thailand
- Khonkaen
  - Muang, Khonkaen, Thailand, 40000
    - Deapartment of Otolaryngology, Srinagarind Hospital, Khonkaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University

Exclusion Criteria:

Patients with cervical lymph nodes metastases requiring neck dissection
Patients that tissue pathology shown anaplastic carcinoma
Patients with clinical or laboratory indicators of coagulation disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group Pressure dressing	Procedure: Pressure dressing Pressure dressing
Experimental: Experimental group Normal dressing	Procedure: Normal dressing Normal dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
amount of fluids collected in the operative bed by ultrasonography Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days	participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Days retained drains Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days	participants will be followed for the duration of hospital stay, an expected average of 4 days
days of hospital stay Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days	participants will be followed for the duration of hospital stay, an expected average of 4 days
complication (bruise,bleeding,wound dehiscence) Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days	participants will be followed for the duration of hospital stay, an expected average of 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

Principal Investigator: Patorn Piromchai, MD, KhonKaen university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (Estimate)

November 16, 2006

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

HE49-1009
ISRCTN52660978 (Registry Identifier: ISRCTN Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Is the Routine Pressure Dressing After Thyroidectomy Necessary?