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OpenTrials
Completed

NCT Number: NCT03108742

Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy

In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.

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Key information

Conditions

Thyroidectomy Dermal Stapler Esthetic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongsik Bae

Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who will have thyroid surgery

Exclusion criteria

  • done thyroid surgery before
  • done any radiotherapy on neck
  • who needs neck dissection
  • laparoscopic ot robotic surgery
  • under 18 years old or over 70 years old
  • bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
  • who used immunosuppressive drugs in 6 months
  • breast feeder or pregnancy
  • who disagrees to do this trial

Treatment and study plan

INSORB

Device

dermal stapler for skin closure

classic intradermal suture

Procedure

intradermal suture for skin closure

Primary outcomes

  1. Modified Stony Brook Scar Evaluation Scale (SBES)

    Time frame: Change from Baseline scar at 6 months

    Evaluate scar

  2. Manchester Scar Scale (MSS)

    Time frame: Change from Baseline scar at 6 months

    Evaluate scar

  3. Visual Analogue Scale (VAS)

    Time frame: Change from Baseline pain at 6 months

    Evaluate pain

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2017
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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