Effect of PDRN in Post-operative Scars

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05149118
• Other study ID #: B-1811-507-005
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Scar

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Erythema and pigmentation at the 3-month follow-up	Erythema Index (EI, arbitrary unit) and the Melanin Index (MI,arbitrary unit)	at 3 months
Secondary	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