Pressure UlcersPhase 4NCT02224638
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
A Phase 4 study testing TheraHoney HD and SkinTegrity in people with Pressure Ulcers, run by Medline Industries at 2 sites in United States.
Trial summary
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- TheraHoney HD and SkinTegrity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Aug 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects of any age
- Sacral wounds with necrotic tissue
Who cannot join
- 3rd degree burns
- know hypersensitivity to products
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Swedish Covenant Hospital
Chicago, Illinois, 606025
Harmony Residential Facility
Chicago, Illinois, 60625
About this study
Official title: Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds
Read the detailed description
Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.
- Conditions
- Pressure Ulcers
- Being tested
- TheraHoney HD, SkinTegrity
- Keywords
- skin ulcers
- Medical subject headings
- Pressure Ulcer, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraHoney HDDevice
Honey
SkinTegrityDevice
Also called Hydrogel
Hydrogel
| Study group | Role | What they receive |
|---|---|---|
| TheraHoney HD | Active comparator | Honey product Receives: Device: TheraHoney HD |
| SkinTegrity | Active comparator | Skin moisturizer Receives: Device: SkinTegrity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Wounds Healed
Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer
Measured: 3 weeks
Secondary outcomes (1)
Number of Participants With Adverse Events
Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Chaiken, RN, Principal investigator, Swedish Covenant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224638
- Sponsor's protocol ID
- R14-028
- Status last verified
- Jul 2019
- First submitted
- 20 Aug 2014
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
- ClinicalTrials.gov ID
- NCT02224638
- Acronym / sponsor ID
- R14-028
- Conditions
- Pressure Ulcers
- Keywords
- skin ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 7 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds
Detailed description
Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
| Arm | Type | Receives |
|---|---|---|
| TheraHoney HD | Active comparator | Device: TheraHoney HDHoney product |
| SkinTegrity | Active comparator | Device: SkinTegritySkin moisturizer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects of any age
- Sacral wounds with necrotic tissue
Key exclusion criteria (2 listed)
- 3rd degree burns
- know hypersensitivity to products
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 |
|---|---|---|
| TheraHoney HDHoney | Device | TheraHoney HD |
| SkinTegrityAlso: HydrogelHydrogel | Device | SkinTegrity |
Primary outcome
Percentage of Wounds Healed
Time frame: 3 weeks
Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer
1 secondary outcome
Number of Participants With Adverse Events
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy Chaiken, RN principal investigator
Swedish Covenant Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TheraHoney HD and SkinTegrity in people with Pressure Ulcers, run by Medline Industries at 2 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Wounds Healed (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2019.