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One injection after neck surgery: a new test for better scar healing

NCT ID NCT07791953

Symptom relief Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a single injection of polynucleotides, a solution called PLINEST One, can improve scar quality after thyroid or parathyroid surgery. Adults aged 40 to 60 having neck surgery for the first time will receive either the polynucleotide injection or a saline placebo right after the wound is closed. Researchers will compare scar appearance, symptoms like pain and itching, and side effects over 24 weeks using standard scar rating scales.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Polynucleotide (PN-HPT) solution, also known as PLINEST One, injected into the wound after surgery
What this could lead to
If it works, this could offer a simple, one-time way to reduce scarring and improve how neck surgery scars look and feel.
What could go wrong
This is a small, early-stage trial, and the injection may not improve scars more than saline. There is also a risk of side effects like pain, swelling, or infection at the injection site.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 40 to 60 years. * Scheduled to undergo open thyroidectomy, thyroid lobectomy, or parathyroidectomy through a standard anterior cervical (Kocher) incision. * Undergoing anterior neck surgery for the first time. * Able to provide written informed consent. * Willing to attend the planned postoperative follow-up visits. * Able and willing to comply with the study procedures. Exclusion Criteria: * Younger than 40 years or older than 60 years. * Previous anterior neck surgery. * Pre-existing scar in the planned incision area. * History of hypertrophic scar or keloid formation. * Previous radiotherapy to the neck. * Active dermatologic disease involving the anterior neck. * Active local or systemic infection. * Uncontrolled diabetes mellitus. * Current use of systemic corticosteroids or immunosuppressive medications. * Pregnancy or breastfeeding. * Known hypersensitivity to fish, salmonid-derived products, polynucleotides, or any component of PLINEST One. * Coagulation disorder or clinically significant bleeding tendency. * Use of anticoagulant therapy that constitutes a contraindication to intradermal injection. * Any contraindication to mesotherapy, intradermal injection, or injectable biostimulant procedures. * Inability or unwillingness to comply with the planned follow-up assessments.

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Conditions

The condition(s) this trial relates to.

severe cutaneous adverse reaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neck scar Postoperative surgical scar Scar Scar formation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Kartal Dr Lutfi Kırdar City Hospital

    Istanbul, Kartal, 34865, Turkey (Türkiye)

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