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New gel may prevent stubborn biofilm in bedsores

NCT ID NCT07391748

Prevention Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a gel containing polyhexanide and biguanide can prevent biofilm (a tough layer of bacteria) from forming in pressure ulcers (bedsores). About 140 adults over 65 with stage II or III bedsores will receive the gel alone or with a special dressing. The goal is to see if this approach helps the wounds heal better within four weeks.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 140 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

65 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: * Bedridden patients, patients with bed-to-chair mobility, or those in a wheelchair. * Presenting one or more category II-III pressure ulcers. * Aged over 65 years. * Patients with laboratory results within normal metabolic values (HbA1c \< 7%). * Patients who, in item 6 "infection/suspected biofilm" of the RESVECH 2.0 index, do not have tissue compatible with biofilm, hypergranulation, or purulent exudate, and never score more than 4 in the other items. * During follow-up, cases that develop signs and symptoms of local infection according to TILI and/or the RESVECH 2.0 index will be considered therapeutic failures, allowing for clinical rescue, but the patient will remain in the intention-to-treat (ITT) analysis. Exclusion Criteria: * Patients who, despite the above, present a deteriorated health status that could influence the outcome, such as terminally ill patients, oncology patients, or those with inflammatory diseases. * Patients in a state of malnutrition according to the Mini Nutritional Assessment (MNA®) scale who are not receiving nutritional supplements, and/or at risk of malnutrition with nutritional deficits. * Patients with pressure ulcers in the perineal area and urinary incontinence (except those with a urinary catheter) and/or fecal incontinence.

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Conditions

The condition(s) this trial relates to.

decubitus ulcer

As listed by the trial registrant

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

Biofilm Biofilm formation Biofilm removal Pressure ulcer ( stage 2-3) Pressure ulcer prevention Pressure ulcers Pressure ulcers stage III

How to take part

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  1. 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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More trials for these conditions

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