New surgical mesh tested in facelifts to improve healing

NCT ID NCT07132892

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study is testing a surgical mesh called Galaflex LITE, made from a material called P4HB, in people having a facelift (rhytidectomy). The goal is to see how the mesh affects skin thickness, elasticity, and scarring. Six healthy adults aged 18-80 who are already scheduled for a facelift will be enrolled. The study is purely for research and does not aim to treat a disease.

What this could mean

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

Active substance
Galaflex Lite Scaffold (a surgical mesh made from poly-4-hydroxybutyrate)
What this could lead to
If successful, this could show that the mesh improves tissue strength and healing after facelift surgery, potentially leading to better cosmetic outcomes.
What could go wrong
This is a very small pilot study with only 6 people, so results may not apply to everyone. The mesh is a device, not a drug, and the study focuses on measuring tissue changes, not treating a disease.

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 6 people

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

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Eligibility Criteria Inclusion Criteria 1. Healthy adults 18-80 years of age 2. Planned/scheduled rhytidectomy at UT Southwestern with the study doctor 3. Willing to return for follow up visits and undergo study evaluations Exclusion Criteria 1. Individuals diagnosed with known reaction to device material (tetracycline hydrochloride, kanamycin sulfate, etc) 2. Individuals who have significant scarring on the test area 3. Individuals with a disorder to negatively affect wound healing

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Conditions

The condition(s) this trial relates to.

Tissue Adhesions

As listed by the trial registrant

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

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States