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Completed

NCT Number: NCT05149118

Effect of PDRN in Post-operative Scars

The investigators aimed to evaluate the efficacy of PDRN administration in early wound healing phase on prevention of post-operative scars after open thyroidectomy.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital

Exclusion criteria

  • age younger than 20 years or older than 60 years
  • history of keloid development
  • requirement for modified radical neck dissection
  • previous neck surgery
  • current pregnancy or breast feeding
  • allergy to PDRN
  • taking medications that may affect inflammation and would healing such as isotretinoin, anti-cancer drugs, high dose corticosteroids, and anticoagulants
  • uncontrolled medical diseases

Treatment and study plan

Polydeoxyribonucleotide (PDRN)

Procedure

A total 1mL of PDRN was injected along the suture line at distance of 1cm in one day and two days after the surgery.

Primary outcomes

  1. modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up

    Time frame: at 3 months

    modified Vancouver Scar Scale (0 normal skin~15 worst)

Secondary outcomes

  1. Subjective symptoms at the 3-month follow-up

    Time frame: at 3 months

    Pain and itching were assessed using a visual analog scale (VAS) ranged from 0 (no) to 10 (worst).

  2. Erythema and pigmentation at the 3-month follow-up

    Time frame: at 3 months

    Erythema Index (EI, arbitrary unit) and the Melanin Index (MI,arbitrary unit)

  3. Scar Height (mm) at the 3-month follow-up

    Time frame: at 3 months

    3D images of the scars were acquired with an Antera 3D® camera (Miravex Limited, Dublin, Ireland)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2021
Registry last updated
Dec 8, 2021

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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