Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
NCT ID: NCT02951000
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2016-02-29
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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platysma suture
running suture of the platysma with 3/0 polyglactin
platysma suture
no platysma suture
no platysma suture
no platysma suture
Interventions
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platysma suture
no platysma suture
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Sven Müller, MD
Role: PRINCIPAL_INVESTIGATOR
University Tuebigen
Locations
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University Hospital Tuebingen
Tübingen, , Germany
Countries
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References
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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.
Other Identifiers
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PLA1
Identifier Type: -
Identifier Source: org_study_id