Effect of PDRN in Post-operative Scars

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

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 Overview

• Status: Completed
• Conditions: Scar
• Intervention / Treatment: Procedure: Polydeoxyribonucleotide (PDRN)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PDRN injected group; The participants in treatment group had received two consecutive injections of PDRN one day and two days after the surgery. A total 1mL of PDRN was injected along the suture line at distance of 1cm in each session.	Procedure: Polydeoxyribonucleotide (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.
No Intervention: Control group; The participants in control group were left untreated.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 3 months
Erythema and pigmentation at the 3-month follow-up	Erythema Index (EI, arbitrary unit) and the Melanin Index (MI,arbitrary unit)	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)	at 3 months

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Jung Won Shin, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B-1811-507-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No