Acute and Chronic WoundsPhase 2/3NCT01286857
An Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
A Phase 2/3 study testing External Suction Interface and a Silicon Film in people with Acute and Chronic Wounds, run by Molnlycke Health Care AB at 3 sites in Sweden.
Trial summary
The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute and Chronic Wounds
- What is being tested?
- External Suction Interface and a Silicon Film
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 3 sitesSweden
- Study dates
- Sep 2010to May 2011
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
- 1cm2 ≤ wound size ≤ 200cm2
- Male or female, 18 years and above
- Signed Informed Consent Form
- Subject understands the written Patient Information
Who cannot join
- Need for frequent dressing changes, i.e.<48 hours between the changes
- Critical ischemia (for wound healing) according to investigator's judgement
- Malignancy in the wound and/or wound margin
- Target ulcer previous not successfully treated with NPWT within 48 hours
- Poorly controlled diabetes according to investigators judgement.
- Osteomyelitis which has been left untreated
Show all 17Show fewer
- Infection which has been left untreated
- High risk for bleeding complications
- Exposed blood vessels, organs or nerves
- Current or within 3 months treatment with chemotherapy or irradiation
- Known hypersensitivity to the dressing material
- Expected technically impossible to seal the film to achieve a vacuum treatment
- Expected non compliance with the Clinical Investigation Plan (CIP)
- Pregnancy
- Subjects not suitable for the investigation according to the investigator's judgement
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
County Hospital
Halmstad, Halmstad, SE-301 85
University Hospital of Örebro
Örebro, 701 85
Hudmottagningen, Sundsvalls sjukhus
Sundsvall, 851 86
About this study
Official title: A Prospective, Open, Non-controlled Proof-of-concept Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.
- Conditions
- Acute and Chronic Wounds
- Being tested
- External Suction Interface and a Silicon Film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Suction Interface and a Silicon FilmDevice
Evaluate the function of a new silicon cover film and an on-top suction device to be used in a NPWT system in the treatment of acute and chronic wounds.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site
Measured: 144 - 288 hours
Secondary outcomes (1)
To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part
Measured: 144-288 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute and Chronic WoundsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286857
- Sponsor's protocol ID
- SIMP 01
- Status last verified
- Jul 2011
- First submitted
- 8 Oct 2010
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Non-controlled Proof-of-concept Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT01286857
- Acronym / sponsor ID
- SIMP 01
- Conditions
- Acute and Chronic Wounds
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Jan 2011 (estimated)
- 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 the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
- 1cm2 ≤ wound size ≤ 200cm2
- Male or female, 18 years and above
- Signed Informed Consent Form
- Subject understands the written Patient Information
Key exclusion criteria (17 listed)
- Need for frequent dressing changes, i.e.<48 hours between the changes
- Critical ischemia (for wound healing) according to investigator's judgement
- Malignancy in the wound and/or wound margin
- Target ulcer previous not successfully treated with NPWT within 48 hours
- Poorly controlled diabetes according to investigators judgement.
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 |
|---|---|---|
| External Suction Interface and a Silicon FilmEvaluate the function of a new silicon cover film and an on-top suction device to be used in a NPWT system in the treatment of acute and chronic wounds. | Device | – |
Primary outcome
To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site
Time frame: 144 - 288 hours
1 secondary outcome
To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part
Time frame: 144-288 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing External Suction Interface and a Silicon Film in people with Acute and Chronic Wounds, run by Molnlycke Health Care AB at 3 sites in Sweden.
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 5 inclusion and 17 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 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site (time frame: 144 - 288 hours). 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 18 Jul 2011.