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

Primary Purpose

Thyroid Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
platysma suture
no platysma suture
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Disease focused on measuring thyroidectomy, postoperative pain, wound healing

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

platysma suture

no platysma suture

Arm Description

running suture of the platysma with 3/0 polyglactin

no platysma suture

Outcomes

Primary Outcome Measures

Postoperative Pain
visual analogue pain scale (0-10)

Secondary Outcome Measures

wound infection
wound infections needing antibiotics or reintervention
scar cosmesis
scar cosmesis according to patient and observer scar assessment scale (POSAS)
Postoperative Pain
visual analogue pain scale (0-10)
Cervical Seroma/Hematoma
clinical apparent swelling verified by ultrasound
Disorders of the functional anatomy of the neck
New onset of clinically described swallowing problems and reduced depression of the corners of the mouth

Full Information

First Posted
October 28, 2016
Last Updated
October 4, 2017
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02951000
Brief Title
Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
Acronym
Platysma
Official Title
Platysma Trial - a Randomized Controlled Trial of Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Disease
Keywords
thyroidectomy, postoperative pain, wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platysma suture
Arm Type
Active Comparator
Arm Description
running suture of the platysma with 3/0 polyglactin
Arm Title
no platysma suture
Arm Type
Active Comparator
Arm Description
no platysma suture
Intervention Type
Procedure
Intervention Name(s)
platysma suture
Intervention Type
Procedure
Intervention Name(s)
no platysma suture
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
visual analogue pain scale (0-10)
Time Frame
Pain at morning of the first postoperative day
Secondary Outcome Measure Information:
Title
wound infection
Description
wound infections needing antibiotics or reintervention
Time Frame
within 14 days postoperative
Title
scar cosmesis
Description
scar cosmesis according to patient and observer scar assessment scale (POSAS)
Time Frame
6 months after surgery
Title
Postoperative Pain
Description
visual analogue pain scale (0-10)
Time Frame
Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery
Title
Cervical Seroma/Hematoma
Description
clinical apparent swelling verified by ultrasound
Time Frame
14 days after surgery
Title
Disorders of the functional anatomy of the neck
Description
New onset of clinically described swallowing problems and reduced depression of the corners of the mouth
Time Frame
At six months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Müller, MD
Organizational Affiliation
University Tuebigen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29579320
Citation
Senne M, Zein R, Falch C, Kirschniak A, Koenigsrainer A, Muller S. Randomized clinical trial of platysma muscle suture versus no suture for wound closure after thyroid surgery. Br J Surg. 2018 May;105(6):645-649. doi: 10.1002/bjs.10829. Epub 2018 Mar 26.
Results Reference
derived

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

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