Effect of PDRN in Post-operative Scars

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05149118

Enrollment

Registered

2021-12-08

Start date

2019-02-01

Completion date

2021-10-31

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar

Brief summary

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

Interventions

PROCEDUREPolydeoxyribonucleotide (PDRN)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up	at 3 months	modified Vancouver Scar Scale (0 normal skin\ 15 worst)

Secondary

Measure	Time frame	Description
Subjective symptoms at the 3-month follow-up	at 3 months	Pain and itching were assessed using a visual analog scale (VAS) ranged from 0 (no) to 10 (worst).
Erythema and pigmentation at the 3-month follow-up	at 3 months	Erythema Index (EI, arbitrary unit) and the Melanin Index (MI,arbitrary unit)
Scar Height (mm) at the 3-month follow-up	at 3 months	3D images of the scars were acquired with an Antera 3D® camera (Miravex Limited, Dublin, Ireland)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026