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

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

Detailed Description
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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.

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

Conditions
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Thyroid Disease

Intervention / Treatment
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* Procedure: platysma suture
* Procedure: no platysma suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | 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 | wound infections needing antibiotics or reintervention | within 14 days postoperative | 
| scar cosmesis | scar cosmesis according to patient and observer scar assessment scale (POSAS) | 6 months after surgery | 
| Postoperative Pain | 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 | clinical apparent swelling verified by ultrasound | 14 days after surgery | 
| Disorders of the functional anatomy of the neck | New onset of clinically described swallowing problems and reduced depression of the corners of the mouth | At six months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, postoperative pain, wound healing