Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
Platysma
Platysma Trial - a Randomized Controlled Trial of Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
1 other identifier
interventional
80
1 country
1
Brief Summary
Influence of the platysma suture on postoperative pain and wound healing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 6, 2017
October 1, 2016
9 months
October 28, 2016
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Pain
visual analogue pain scale (0-10)
Pain at morning of the first postoperative day
Secondary Outcomes (5)
wound infection
within 14 days postoperative
scar cosmesis
6 months after surgery
Postoperative Pain
Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery
Cervical Seroma/Hematoma
14 days after surgery
Disorders of the functional anatomy of the neck
At six months postoperative
Study Arms (2)
platysma suture
ACTIVE COMPARATORrunning suture of the platysma with 3/0 polyglactin
no platysma suture
ACTIVE COMPARATORno platysma suture
Interventions
Eligibility Criteria
You may qualify if:
- primary thyroid surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tuebingen
Tübingen, 72076, Germany
Related Publications (1)
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.
PMID: 29579320DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sven Müller, MD
University Tuebigen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 1, 2016
Study Start
February 1, 2016
Primary Completion
November 1, 2016
Study Completion
June 1, 2017
Last Updated
October 6, 2017
Record last verified: 2016-10