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

Not Applicable

Completed

• Conditions: Thyroid Disease
• Interventions: Procedure: no platysma suture; Procedure: platysma suture

• Registration Number: NCT02951000
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-10
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-31
• Primary Completion: 2016-11
• Study First Posted: 2016-11-01
• Study Completion: 2017-06
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no platysma suture	no platysma suture	no platysma suture
platysma suture	platysma suture	running suture of the platysma with 3/0 polyglactin

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	Pain at morning of the first postoperative day	visual analogue pain scale (0-10)

Secondary Outcome Measures

Name	Time	Method
scar cosmesis	6 months after surgery	scar cosmesis according to patient and observer scar assessment scale (POSAS)
wound infection	within 14 days postoperative	wound infections needing antibiotics or reintervention
Cervical Seroma/Hematoma	14 days after surgery	clinical apparent swelling verified by ultrasound
Postoperative Pain	Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery	visual analogue pain scale (0-10)
Disorders of the functional anatomy of the neck	At six months postoperative	New onset of clinically described swallowing problems and reduced depression of the corners of the mouth

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tubingen, Germany