Open Chest WoundsNCT02803164
Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
A study testing Wound Vacuum-assisted dressing in people with Open Chest Wounds, run by Mayo Clinic at 1 site in United States.
Trial summary
Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Chest Wounds
- What is being tested?
- Wound Vacuum-assisted dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to 3 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.
Who cannot join
- Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
- Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.
- Allergy to acrylic products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Efficacy of Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.
- Conditions
- Open Chest Wounds
- Being tested
- Wound Vacuum-assisted dressing, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound Vacuum-assisted dressingDevice
Also called Wound Vacuum-assisted dressing (V-AD)
The NPWT system (V.A.C. Therapy System, KCI USA Inc.) consisted of a medical-grade non-adherent polyvinyl alcohol white foam applied directly to the infected surface, followed by an open-pore reticulated polyurethane black foam cut to fit the wound and covered by a transparent air-tight adhesive drape. A suction cup with tubing was placed over a small slit on the drape and connected to a suction machine (V.A.C. ULTA Therapy Unit).
Control groupOther
Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum-assisted dressing | Other | Eligible subjects will receive negative pressure wound therapy during surgery. Receives: Device: Wound Vacuum-assisted dressing |
| Historical control group for comparison | Other | Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Negative Pressure Wound Therapy (NWPT)
The total number of days of receiving NWPT
Measured: 12 month follow up
Secondary outcomes (2)
Wound Closure
The total number of days to wound closure
Measured: 12 months
Length of Hospital Stay
The total number of days in hospital
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start10 Feb 2017
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
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 Chest WoundsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathew Thomas, M.D., Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803164
- Sponsor's protocol ID
- 16-002486
- Status last verified
- Sep 2021
- First submitted
- 14 Jun 2016
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
- ClinicalTrials.gov ID
- NCT02803164
- Acronym / sponsor ID
- 16-002486
- Conditions
- Open Chest Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 29 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum-assisted dressing | Other | Device: Wound Vacuum-assisted dressingEligible subjects will receive negative pressure wound therapy during surgery. |
| Historical control group for comparison | Other | Other: Control groupRetrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.
Key exclusion criteria (3 listed)
- Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
- Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.
- Allergy to acrylic 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 |
|---|---|---|
| Wound Vacuum-assisted dressingAlso: Wound Vacuum-assisted dressing (V-AD)The NPWT system (V.A.C. Therapy System, KCI USA Inc.) consisted of a medical-grade non-adherent polyvinyl alcohol white foam applied directly to the infected surface, followed by an open-pore reticulated polyurethane black foam cut to fit the wound and covered by a transparent air-tight adhesive drape. A suction cup with tubing was placed over a small slit on the drape and connected to a suction machine (V.A.C. ULTA Therapy Unit). | Device | Vacuum-assisted dressing |
| Control groupRetrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques. | Other | Historical control group for comparison |
Primary outcome
Duration of Negative Pressure Wound Therapy (NWPT)
Time frame: 12 month follow up
The total number of days of receiving NWPT
2 secondary outcomes
Wound Closure
Time frame: 12 months
Length of Hospital Stay
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Vacuum-assisted dressing in people with Open Chest Wounds, run by Mayo Clinic 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 1 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: finished, as of the sponsor's last update on 29 Sep 2021. 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 29 Sep 2021). 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?
Duration of Negative Pressure Wound Therapy (NWPT) (time frame: 12 month follow up). 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 29 Sep 2021.