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

University Hospital Tuebingen

Status: Completed

Conditions: Thyroid Disease

Treatments: Procedure: platysma suture; Procedure: no platysma suture

Study type: Interventional

Funder types: Other

Identifiers

NCT02951000

PLA1

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

platysma suture

Active Comparator group

Description:

running suture of the platysma with 3/0 polyglactin

Treatment:

Procedure: platysma suture

no platysma suture

Active Comparator group

Description:

no platysma suture

Treatment:

Procedure: no platysma suture