Incontinence-associated DermatitisNCT07899060
Safety and Efficacy of RashEndZ Wound Aeration Technology
A study testing Dynamic Oxygen Skin Therapy (DOST) and Standard Wound Care in people with Incontinence-associated Dermatitis and Decubitus Ulcer, run by RashEndZ Inc. at 1 site in United States.
Trial summary
The aim of this study is to determine the safety and efficacy of RashEndZ therapeutic liner technology and Dynamic Oxygen Skin Therapy in improving symptoms and expediting healing of IAD and DU in adult patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Incontinence-associated Dermatitis, Decubitus Ulcer
- What is being tested?
- Dynamic Oxygen Skin Therapy (DOST) and Standard Wound Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2016to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients diagnosed with stage 1 or 2 wounds, IAD, or pressure ulcers on any location of the body.
- Age: any adult age.
- Weight: any weight.
- Signed informed consent.
Who cannot join
- Clinical instability (e.g. hemodynamic instability necessitating vasopressors and/or mechanical ventilation)
- Urinary catheterization
- Known terminal illnesses
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Hospital Tampa (AdventHealth)
Tampa, Florida
About this study
Official title: Safety and Efficacy of RashEndZ Wound Aeration Technology and Dynamic Oxygen Skin Therapy (DOST), a Topical Oxygen Therapy, in Adult Patients With Early Stage Incontinent Associated Dermatitis and Decubitus Ulcers.
The aim of this study is to determine the safety and efficacy of RashEndZ therapeutic liner technology and Dynamic Oxygen Skin Therapy in improving symptoms and expediting healing of IAD and DU in adult patients.
Read the detailed description
To achieve this aim, this study will evaluate the following objectives:
Objective 1:
Assess the safety and tolerability of the RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy for the treatment of Incontinent Associated Dermatitis (IAD) and Decubitus Ulcers (DU) in adult patients.
Objective 2:
Compare treatment responses (symptomatic and clinical) to RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy and current standard of care in patients with IAD and DU
Objective 3:
Compare time course of symptom improvement in IAD and DU patients treated with RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy and current standards of care
The hypotheses to be tested in this study are as follows:
- RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy is well tolerated by patients with IAD and/or DU
- In patients with IAD or DU, the beneficial treatment responses are higher in patients treated with RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy compared to patients treated with current standards of care
- RashEndZ therapeutic liner technology and Dynamic Oxygen Skin Therapy reduce healing time in patients with IAD and DU at a faster rate compared to patients with IAD and DU treated with current standard of care.
- Being tested
- Dynamic Oxygen Skin Therapy (DOST), Standard Wound Care
- Keywords
- Topical Oxygen Therapy, Continuous Wound Oxygenation, Pressure Injury, Moisture-Associated Skin Damage, Occlusive Wound Dressing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Oxygen Skin Therapy (DOST)Device
Also called Topical Oxygen Therapy (TOT), RashEndZ Advanced Occlusive Wound Dressing (AOWD)
Continuous application of respiratory oxygen, at 3-4 L/min, to each wound using the patented RashEndZ Wound Aeration Technology
Standard Wound CareOther
Existing protocols typically include topical medications and barrier ointments
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Application of Dynamic Oxygen Skin Therapy, a non-pressurized, continuous topical oxygen therapy at 3-4 L/min. Receives: Device: Dynamic Oxygen Skin Therapy (DOST) |
| Control Group | Active comparator | Application of standard therapies for candidate wound types Receives: Other: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device-Related Adverse Events
Count of participants with adverse events, including skin irritation or patient-reported discomfort, attributed to Dynamic Oxygen Skin Therapy (DOST) delivered via RashEndZ Wound Aeration Technology, recorded on daily assessment datasheets.
Measured: Start of treatment until wound closure or discharge, up to 8 days
Number of Participants Who Discontinued DOST Due to Intolerance
Count of participants whose DOST treatment was stopped because side effects or adverse events required cessation of DOST and initiation of standard-of-care treatment, per the protocol definition of "poorly tolerated."
Measured: Start of treatment until end of treatment, up to 8 days
Secondary outcomes (2)
Rate of Change in IADS Score per Treatment Day
Change from baseline in IADS score (range 0-52, lower scores indicate less severe IAD) divided by number of treatment days, to describe the time course of change in each group.
Measured: Baseline (enrollment) to end of treatment, up to 8 days
Change From Baseline in IADS Score at End of Treatment
Incontinence-Associated Dermatitis Severity (IADS) score (Borchert et al., 2010; range 0-52, lower scores indicate less severe IAD) at end of treatment minus score at enrollment, reported descriptively for each group in participants with IAD.
Measured: Baseline (enrollment) and end of treatment, up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start21 Jun 2016
- Primary completion2 Mar 2017
- Study completion15 Mar 2018
Why it stopped: Enrollment challenges, limited sponsor resources, and a smaller than expected eligible patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incontinence-associated DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label study with concurrent standard-of-care control. Protocol amended to v1.3 (IRB approved 02/21/2017) to a single-arm safety study; control enrollment was discontinued. Two participants were assigned to standard of care before the amendment.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RashEndZ Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Arnold, M.D., Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899060
- Sponsor's protocol ID
- 2016-015-839843-4
- Other IDs
- 2016-015-839843-1
- Status last verified
- Oct 2026
- First submitted
- 29 Mar 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nuutila K, Eriksson E. Moist Wound Healing with Commonly Available Dressings. Adv Wound Care (New Rochelle). 2021 Dec;10(12):685-698. doi: 10.1089/wound.2020.1232. Epub 2021 Feb 11.
PubMed 32870777Borchert K, Bliss DZ, Savik K, Radosevich DM. The incontinence-associated dermatitis and its severity instrument: development and validation. J Wound Ostomy Continence Nurs. 2010 Sep-Oct;37(5):527-35. doi: 10.1097/WON.0b013e3181edac3e.
PubMed 20736860
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of RashEndZ Wound Aeration Technology and Dynamic Oxygen Skin Therapy (DOST), a Topical Oxygen Therapy, in Adult Patients With Early Stage Incontinent Associated Dermatitis and Decubitus Ulcers.
- ClinicalTrials.gov ID
- NCT07899060
- Acronym / sponsor ID
- 2016-015-839843-4
- Keywords
- Topical Oxygen Therapy, Continuous Wound Oxygenation, Pressure Injury, Moisture-Associated Skin Damage, Occlusive Wound Dressing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges, limited sponsor resources, and a smaller than expected eligible patient population.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RashEndZ Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the safety and efficacy of RashEndZ therapeutic liner technology and Dynamic Oxygen Skin Therapy in improving symptoms and expediting healing of IAD and DU in adult patients.
Detailed description
To achieve this aim, this study will evaluate the following objectives:
Objective 1:
Assess the safety and tolerability of the RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy for the treatment of Incontinent Associated Dermatitis (IAD) and Decubitus Ulcers (DU) in adult patients.
Objective 2:
Compare treatment responses (symptomatic and clinical) to RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy and current standard of care in patients with IAD and DU
Objective 3:
Compare time course of symptom improvement in IAD and DU patients treated with RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy and current standards of care
The hypotheses to be tested in this study are as follows:
- RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy is well tolerated by patients with IAD and/or DU
- In patients with IAD or DU, the beneficial treatment responses are higher in patients treated with RashEndZ therapeutic liner technology with Dynamic Oxygen Skin Therapy compared to patients treated with current standards of care
- RashEndZ therapeutic liner technology and Dynamic Oxygen Skin Therapy reduce healing time in patients with IAD and DU at a faster rate compared to patients with IAD and DU treated with current standard of care.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label study with concurrent standard-of-care control. Protocol amended to v1.3 (IRB approved 02/21/2017) to a single-arm safety study; control enrollment was discontinued. Two participants were assigned to standard of care before the amendment.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Dynamic Oxygen Skin Therapy (DOST)Application of Dynamic Oxygen Skin Therapy, a non-pressurized, continuous topical oxygen therapy at 3-4 L/min. |
| Control Group | Active comparator | Other: Standard Wound CareApplication of standard therapies for candidate wound types |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Patients diagnosed with stage 1 or 2 wounds, IAD, or pressure ulcers on any location of the body.
- Age: any adult age.
- Weight: any weight.
- Signed informed consent.
Key exclusion criteria (3 listed)
- Clinical instability (e.g. hemodynamic instability necessitating vasopressors and/or mechanical ventilation)
- Urinary catheterization
- Known terminal illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Oxygen Skin Therapy (DOST)Also: Topical Oxygen Therapy (TOT), RashEndZ Advanced Occlusive Wound Dressing (AOWD)Continuous application of respiratory oxygen, at 3-4 L/min, to each wound using the patented RashEndZ Wound Aeration Technology | Device | Treatment Group |
| Standard Wound CareExisting protocols typically include topical medications and barrier ointments | Other | Control Group |
Primary outcome
Number of Participants With Device-Related Adverse Events
Time frame: Start of treatment until wound closure or discharge, up to 8 days
Count of participants with adverse events, including skin irritation or patient-reported discomfort, attributed to Dynamic Oxygen Skin Therapy (DOST) delivered via RashEndZ Wound Aeration Technology, recorded on daily assessment datasheets.
Number of Participants Who Discontinued DOST Due to Intolerance
Time frame: Start of treatment until end of treatment, up to 8 days
Count of participants whose DOST treatment was stopped because side effects or adverse events required cessation of DOST and initiation of standard-of-care treatment, per the protocol definition of "poorly tolerated."
2 secondary outcomes
Rate of Change in IADS Score per Treatment Day
Time frame: Baseline (enrollment) to end of treatment, up to 8 days
Change From Baseline in IADS Score at End of Treatment
Time frame: Baseline (enrollment) and end of treatment, up to 8 days
Results and safety
The study was stopped early (reason given: Enrollment challenges, limited sponsor resources, and a smaller than expected eligible patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 32870777Nuutila K, Eriksson E. Moist Wound Healing with Commonly Available Dressings. Adv Wound Care (New Rochelle). 2021 Dec;10(12):685-698. doi: 10.1089/wound.2020.1232. Epub 2021 Feb 11.
- Background: PubMed 20736860Borchert K, Bliss DZ, Savik K, Radosevich DM. The incontinence-associated dermatitis and its severity instrument: development and validation. J Wound Ostomy Continence Nurs. 2010 Sep-Oct;37(5):527-35. doi: 10.1097/WON.0b013e3181edac3e.
- RashEndZ, Inc. Corporate WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Arnold, M.D. principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Oxygen Skin Therapy (DOST) and Standard Wound Care in people with Incontinence-associated Dermatitis and Decubitus Ulcer, run by RashEndZ Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment challenges, limited sponsor resources, and a smaller than expected eligible patient population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device-Related Adverse Events (time frame: Start of treatment until wound closure or discharge, up to 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07899060, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.