Effect of PDRN in Post-operative Scars
Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedFirst Submitted
Initial submission to the registry
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedDecember 8, 2021
November 1, 2021
2.7 years
November 9, 2021
November 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Subjective symptoms at the 3-month follow-up
at 3 months
Erythema and pigmentation at the 3-month follow-up
at 3 months
Scar Height (mm) at the 3-month follow-up
at 3 months
Study Arms (2)
PDRN injected group
EXPERIMENTALThe 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.
Control group
NO INTERVENTIONThe participants in control group were left untreated.
Interventions
A total 1mL of PDRN was injected along the suture line at distance of 1cm in one day and two days after the surgery.
Eligibility Criteria
You may qualify if:
- Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung Won Shin, M.D., Ph.D.
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 9, 2021
First Posted
December 8, 2021
Study Start
February 1, 2019
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
December 8, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share