Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery (Platysma)

October 4, 2017 updated by: University Hospital Tuebingen

Platysma Trial - a Randomized Controlled Trial of Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery

Influence of the platysma suture on postoperative pain and wound healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Does a running platysma suture after primary thyroid resection alter direct postoperative pain, wound healing and long term cosmetic results.

Primary outcome measure is if the lack of a platysma-Suture decreases the postoperative pain (detected by the visual pain score 0-10) and reduces the pain medication (detected by the cumulative NSAID and opioid treatment per patient). The second Question to be answered is if the cosmetic scar result (detected by the Patient and Observer Scar Assessment Score) 6 month after thyroidectomy is better in the intervention group (no Platysma-Suture) or not.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Germany
      • Tubingen, Germany, 72076
        • University Hospital Tuebingen

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

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary thyroid surgery

Exclusion Criteria:

  • previous neck surgery
  • application of wound drainages
  • preoperative diagnosed malignancy
  • surgical extension beyond thyroid resection (e.g. lymphadenectomy)
  • preexisting coagulopathy
  • preexisting chronic pain syndromes
  • preexisting dependency on pain reliefs
  • preexisting disorders in wound healing (e.g. diabetes mellitus)
  • intolerance to any study medication

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: platysma suture
running suture of the platysma with 3/0 polyglactin
Procedure: platysma suture
Active Comparator: no platysma suture
Procedure: no platysma suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: Pain at morning of the first postoperative day
visual analogue pain scale (0-10)
Pain at morning of the first postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound infection
Time Frame: within 14 days postoperative
wound infections needing antibiotics or reintervention
within 14 days postoperative
scar cosmesis
Time Frame: 6 months after surgery
scar cosmesis according to patient and observer scar assessment scale (POSAS)
6 months after surgery
Postoperative Pain
Time Frame: Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery
visual analogue pain scale (0-10)
Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery
Cervical Seroma/Hematoma
Time Frame: 14 days after surgery
clinical apparent swelling verified by ultrasound
14 days after surgery
Disorders of the functional anatomy of the neck
Time Frame: At six months postoperative
New onset of clinically described swallowing problems and reduced depression of the corners of the mouth
At six months postoperative

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Sven Müller, MD, University Tuebigen

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 (Actual)

February 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pla1 (Registry Identifier: Placenta1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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