Open Wound Abdominal WallNCT02246608
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
A study of Open Wound Abdominal Wall and Wound Non Healing, run by Kettering Health Network at 1 site in United States.
Trial summary
This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Open Wound Abdominal Wall, Wound Non Healing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jan 2018
- Phase
- Interventional
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of infection.
- HbA1C < 8 (if patient is diabetic)
- Adequate nutrition including albumin above 2.0 and prealbumin above 15.
Who cannot join
- Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues.
- Patients with Infected wounds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)
This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.
Read the detailed description
In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either:
- Oasis® matrix, applied to the wound, along with standard of care including NPWT OR
- Standard foam, applied to the wound prior to activation of NPWT, which is standard care.
Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation canister will be collected for specimen analysis.
The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth factors and interleukins in fluid evacuated from the wound.
- Conditions
- Open Wound Abdominal Wall, Wound Non Healing
- Being tested
- NPWT Standard of Care plus Oasis wound product, Routine NPWT Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWT Standard of Care plus Oasis wound productDevice
Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.
Routine NPWT Standard of CareDevice
Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
| Study group | Role | What they receive |
|---|---|---|
| Routine NPWT Standard of Care | Active comparator | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed. Receives: Device: Routine NPWT Standard of Care |
| NPWT Standard of Care plus Oasis wound product | Experimental | Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied in addition to standard of care dressing. Receives: Device: NPWT Standard of Care plus Oasis wound product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure Rate of Non-healing Wounds
Wound dimensions will be measured weekly and monitored for changes
Measured: 12 weeks
Secondary outcomes (1)
Growth Factors
Fluid collected from the wound will be examined for the presence of growth factors and interleukins.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2017
- Study completionJan 2018
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 Open Wound Abdominal WallStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Simman, MD, Principal investigator, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246608
- Sponsor's protocol ID
- KHN-RSWound-P14-N01
- Status last verified
- Aug 2018
- First submitted
- 18 Sep 2014
- Last updated
- 27 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)
- ClinicalTrials.gov ID
- NCT02246608
- Acronym / sponsor ID
- KHN-RSWound-P14-N01
- Conditions
- Open Wound Abdominal Wall, Wound Non Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Posted 21 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.
Detailed description
In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either:
- Oasis® matrix, applied to the wound, along with standard of care including NPWT OR
- Standard foam, applied to the wound prior to activation of NPWT, which is standard care.
Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation canister will be collected for specimen analysis.
The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth factors and interleukins in fluid evacuated from the wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine NPWT Standard of Care | Active comparator | Device: Routine NPWT Standard of CarePrior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed. |
| NPWT Standard of Care plus Oasis wound product | Experimental | Device: NPWT Standard of Care plus Oasis wound productPrior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied in addition to standard of care dressing. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of infection.
- HbA1C < 8 (if patient is diabetic)
- Adequate nutrition including albumin above 2.0 and prealbumin above 15.
Key exclusion criteria (2 listed)
- Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues.
- Patients with Infected wounds.
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 |
|---|---|---|
| NPWT Standard of Care plus Oasis wound productOasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns. | Device | NPWT Standard of Care plus Oasis wound product |
| Routine NPWT Standard of CareSpecialized material, often foam, designed to protect the wound and promote healing during NPWT. | Device | Routine NPWT Standard of Care |
Primary outcome
Closure Rate of Non-healing Wounds
Time frame: 12 weeks
Wound dimensions will be measured weekly and monitored for changes
1 secondary outcome
Growth Factors
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Richard Simman, MD principal investigator
Kettering Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Open Wound Abdominal Wall and Wound Non Healing, run by Kettering Health Network 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 3 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 27 Sep 2018. 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?
Yes. Results are posted in the registry (first posted 21 Aug 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?
Closure Rate of Non-healing Wounds (time frame: 12 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 27 Sep 2018.