Effect of PDRN in Post-operative Scars

Phase 4

Completed

• Conditions: Scar
• Interventions: Procedure: Polydeoxyribonucleotide (PDRN)

• Registration Number: NCT05149118
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2021-11
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDRN injected group	Polydeoxyribonucleotide (PDRN)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of