Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy

February 21, 2019 updated by: Dongsik Bae, Inje University
In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

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

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who will have thyroid surgery

Exclusion Criteria:

  1. done thyroid surgery before
  2. done any radiotherapy on neck
  3. who needs neck dissection
  4. laparoscopic ot robotic surgery
  5. under 18 years old or over 70 years old
  6. bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
  7. who used immunosuppressive drugs in 6 months
  8. breast feeder or pregnancy
  9. who disagrees to do this trial

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dermal stapler
Device: INSORB
dermal stapler for skin closure
Active Comparator: classic intradermal suture
Procedure: classic intradermal suture
intradermal suture for skin closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Stony Brook Scar Evaluation Scale (SBES)
Time Frame: Change from Baseline scar at 6 months
Evaluate scar
Change from Baseline scar at 6 months
Manchester Scar Scale (MSS)
Time Frame: Change from Baseline scar at 6 months
Evaluate scar
Change from Baseline scar at 6 months
Visual Analogue Scale (VAS)
Time Frame: Change from Baseline pain at 6 months
Evaluate pain
Change from Baseline pain at 6 months

Collaborators and Investigators

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

Sponsor

Inje University

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 (Actual)

October 1, 2016

Primary Completion (Actual)

January 28, 2019

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-12-010-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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Locations

3
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