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New dressing aims to ease pain after HS surgery

NCT ID NCT07316192

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares a new wound dressing, Pelashield PainGuard, to the standard Restrata dressing for people with severe hidradenitis suppurativa (HS) who need surgery. The new dressing contains silver to fight bacteria and lidocaine to numb pain. Researchers will track healing time, infections, and painkiller use in 10 patients, comparing them to past cases. The goal is to see if the new dressing improves recovery.

What this could mean

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

Active substance
Pelashield PainGuard wound dressing (contains silver and lidocaine)
What this could lead to
If it works, this could offer a better healing experience for HS patients after surgery, with less pain and fewer infections.
What could go wrong
This is a very small study (10 people) and not randomized, so results may not apply to everyone. The new dressing might not outperform the current standard.

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 10 people

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

Started

Dec 2025

Expected to finish

Nov 2026

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 years and older

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 (≥18 years) with a confirmed clinical diagnosis of HS requiring wide surgical excision. * Ability to provide informed consent in English. * Willingness and ability to attend routine postoperative follow-up visits to monitor healing and readiness for second-stage closure. Exclusion Criteria: * Non-English-speaking patients (due to consent and follow-up communication limitations). * Known allergy or hypersensitivity to wound matrix components (polyvinyl alcohol), local anesthetics, or silver. * Known sensitivity to lidocaine or history of cardiac conditions contraindicating lidocaine use (e.g., severe heart block, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome). * Pregnancy or active breastfeeding. * Severe immunosuppression (e.g., chemotherapy within 3 months, solid organ transplant, uncontrolled HIV with CD4 \<200, or chronic systemic steroids \>10 mg prednisone-equivalent/day). * Uncontrolled diabetes (most recent HbA1c \>10% if available within 3 months). * Active systemic infection or sepsis at time of surgery. * Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate).

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Conditions

The condition(s) this trial relates to.

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

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

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  3. A doctor treating you

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Contacts and locations

Locations

  • University Hospital

    RECRUITING

    Newark, New Jersey, 07103, United States

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