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Completed

NCT Number: NCT02951000

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

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

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Key information

Conditions

Thyroid Disease Endocrine System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thyroid Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platysma suture

Procedure

no platysma suture

Procedure

Primary outcomes

  1. Postoperative Pain

    Time frame: Pain at morning of the first postoperative day

    visual analogue pain scale (0-10)

Secondary outcomes

  1. wound infection

    Time frame: within 14 days postoperative

    wound infections needing antibiotics or reintervention

  2. scar cosmesis

    Time frame: 6 months after surgery

    scar cosmesis according to patient and observer scar assessment scale (POSAS)

  3. 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)

  4. Cervical Seroma/Hematoma

    Time frame: 14 days after surgery

    clinical apparent swelling verified by ultrasound

  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: Platysma

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 1, 2016
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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