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

Thyroid Disease Clinical Trial

— Platysma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951000
• Other study ID #: PLA1
• Status: Completed
• Phase: N/A
• First received: October 28, 2016
• Last updated: October 4, 2017
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Disease
• Thyroid Diseases

Intervention

Procedure:
• platysma suture

• no platysma suture

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tubingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	visual analogue pain scale (0-10)	Pain at morning of the first postoperative day
Secondary	wound infection	wound infections needing antibiotics or reintervention	within 14 days postoperative
Secondary	scar cosmesis	scar cosmesis according to patient and observer scar assessment scale (POSAS)	6 months after surgery
Secondary	Postoperative Pain	visual analogue pain scale (0-10)	Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery
Secondary	Cervical Seroma/Hematoma	clinical apparent swelling verified by ultrasound	14 days after surgery
Secondary	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