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

U

University Hospital Tuebingen

Status

Completed

Conditions

Thyroid Disease

Treatments

Procedure: platysma suture
Procedure: no platysma suture

Study type

Interventional

Funder types

Other

Identifiers

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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