ScarPhase 4NCT05149118
Effect of PDRN in Post-operative Scars
A Phase 4 study testing Polydeoxyribonucleotide (PDRN) in people with Scar, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Scar
- What is being tested?
- Polydeoxyribonucleotide (PDRN)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2019to 31 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: 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.
- Conditions
- Scar
- Being tested
- Polydeoxyribonucleotide (PDRN)
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polydeoxyribonucleotide (PDRN)Procedure or surgery
A total 1mL of PDRN was injected along the suture line at distance of 1cm in one day and two days after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| PDRN injected group | Experimental | 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. Receives: Procedure: Polydeoxyribonucleotide (PDRN) |
| Control group | No intervention | The participants in control group were left untreated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up
modified Vancouver Scar Scale (0 normal skin~15 worst)
Measured: at 3 months
Secondary outcomes (3)
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).
Measured: at 3 months
Erythema and pigmentation at the 3-month follow-up
Erythema Index (EI, arbitrary unit) and the Melanin Index (MI,arbitrary unit)
Measured: 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)
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Feb 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Won Shin, Seoul National University Bundang Hospital
- Investigators
- Jung Won Shin, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149118
- Sponsor's protocol ID
- B-1811-507-005
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05149118
- Acronym / sponsor ID
- B-1811-507-005
- Conditions
- Scar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDRN injected group | Experimental | Procedure: 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. |
| Control group | No intervention | –The participants in control group were left untreated. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | PDRN injected group |
Primary outcome
modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up
Time frame: at 3 months
modified Vancouver Scar Scale (0 normal skin~15 worst)
3 secondary outcomes
Subjective symptoms at the 3-month follow-up
Time frame: at 3 months
Erythema and pigmentation at the 3-month follow-up
Time frame: at 3 months
Scar Height (mm) at the 3-month follow-up
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Won Shin, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polydeoxyribonucleotide (PDRN) in people with Scar, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Vancouver Scar Scale (0 normal skin~15 worst) at the 3-month follow-up (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.