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Which mattress heals bedsores faster? new study has answers

NCT ID NCT03522714

Disease control Sponsor: Northwestern 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested two types of special mattresses—the Fluid Immersion Simulation (FIS) system and the Air Fluidized Bed (AFB)—to see which helps heal surgically closed pressure ulcers (bedsores) better. Eighty adults with stage III or IV bedsores were randomly assigned to one mattress after surgery. The main goal was to check wound closure after 2 weeks and compare complication rates like reopening or infection.

What this could mean

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

Active substance
Fluid Immersion Simulation System (special mattress) vs. Air Fluidized Bed (special mattress)
What this could lead to
If one mattress works better, it could improve healing and reduce complications after pressure ulcer surgery.
What could go wrong
This is a small, completed trial with only 80 participants, so results may not apply to everyone. The study compares devices, not a new drug or cure.

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

80 people

The number who actually took part.

Started

Aug 2015

Finished

Dec 2020

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 85 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: 1. will be admitted as an inpatient 2. is ≥ 18 years of age and ≤ 85 years of age at time of consent 3. is able to provide his/her own informed consent 4. is deemed by the investigators to be reasonably compliant 5. has a pressure ulcer meeting criteria for stage III or IV 6. has not participated in a clinical trial within the past 30 days 7. has a 30-day wound history available if the wound has been previously treated Exclusion Criteria: 1. has a life expectancy of \< 12 months 2. is not healthy enough to undergo surgery for any reason 3. has a history of radiation therapy 4. is, in the opinion of the investigator, noncompliant 5. has a history of \> 3 closures of pressure ulcers in the same site 6. has a history of a bleeding disorder 7. has severe fecal incontinence

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Conditions

The condition(s) this trial relates to.

decubitus ulcer ulcer disease

As listed by the trial registrant

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

Pressure ulcer

Contacts and locations

Locations

  • Northwestern Memorial Hospital Plastic Surgery

    Chicago, Illinois, 60611, United States

More trials for these conditions

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