Effect of PDRN in Post-operative Scars

NCT ID: NCT05149118

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-10-31

Brief Summary

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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

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Conditions

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Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Polydeoxyribonucleotide (PDRN)

Intervention Type 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.

Control group

The participants in control group were left untreated.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Won Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Won Shin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1811-507-005

Identifier Type: -

Identifier Source: org_study_id