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New dressing may reduce scarring after breast reconstruction

NCT ID NCT05377723

Symptom relief Sponsor: Stanford University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study tests whether a special silicone dressing (Neodyne embrace) can improve the appearance of abdominal scars in women who had breast reconstruction using tissue from their belly. Thirty women will have part of their incision treated with the dressing and the other part left untreated. Researchers will compare scar appearance six months after surgery using photos and questionnaires.

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

30 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 2026

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 89 years

Sex

Female participants only

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: 1. Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation. 2. Appearance of subject's incision is aesthetically similar across length of incision 3. Age \>18 4. Subject has the ability to read and comprehend as required by the protocol and the informed consent. 5. Subject must be able to provide written informed consent prior to participation in the study. Exclusion Criteria: 1. Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus. 2. Subjects diagnosed with scleroderma. 3. Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives. 4. Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application. 5. Subjects with inability to maintain adequate care of incision. 6. Subjects with a weight loss of \> 100 lbs within 6 months from date of surgery. 7. Subjects who currently smoke. 8. Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment. 9. Subject does not qualify for the study in the opinion of the investigators.

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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.

Breast reconstruction Cicatrix

Contacts and locations

Locations

  • Stanford University Medical Center

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.