Effect of PDRN in Post-operative Scars

Seoul National University Bundang Hospital22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Scar

Interventions

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Outcomes

Primary Outcomes

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

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

Time frame: at 3 months

Secondary Outcomes

Subjective symptoms at the 3-month follow-up

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

Time frame: at 3 months

Erythema and pigmentation at the 3-month follow-up

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

Time frame: at 3 months

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

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

Time frame: at 3 months

Data from ClinicalTrials.gov

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