Acute Non Infected WoundsNCT01195896
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds
A study testing New NPWT system in people with Acute Non Infected Wounds and Non Infected Post Surgical Wounds, run by Molnlycke Health Care AB at 1 site in Germany.
Trial summary
The investigation is designed as a prospective, open, non-controlled clinical investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Non Infected Wounds, Non Infected Post Surgical Wounds
- What is being tested?
- New NPWT system
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Sep 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- 3 cm2 ≤ Wound size ≤ 300 cm2
- Male or female ≥18 years
- Signed Informed Consent Form
Who cannot join
- Need for frequent dressing changes, i.e.<48 hours between the changes
- Dry wounds
- Malignancy in the wound and/or wound margin
- Untreated osteomyelitis
- Untreated infection waiting for other intervention
- Unexplored fistulas
Show all 18Show fewer
- > 10% necrotic tissue with eschar present after debridement
- High risk for bleeding complications (including subject treated with anticoagulants that are associated with 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
- Pregnancy
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
- Target ulcer previously not successfully treated with NPWT within 48 hours from NPWT start
- Subject unable to understand written patient information due to medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds.
The investigation is designed as a prospective, open, non-controlled clinical investigation.
Read the detailed description
Wounds to be treated under this protocol should be acute non-infected wounds or post surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for a maximum duration of 3 weeks. All subjects will receive continuous negative pressure treatment with the new NPWT system with a pressure level of -120 mmHg or according to clinicians' instruction based on the indication.
10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and who have signed and dated a written informed consent.
The subjects will be consecutively allocated to a specific subject identification code. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.
Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of wound infections according to clinical routine.
- Being tested
- New NPWT system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New NPWT systemDevice
According clinical routine (Instruction for Use)
What is being measured
The primary outcome is the main question the study is designed to answer.
Granulation tissue formation
To assess the wound healing and granulation tissue formation when using the NPWT system
Measured: maximum 3 weeks
Secondary outcomes (1)
Handling of NPWT system
To investigate the pain level at dressing removal To visually check exudate removal To investigate the ease of use for the subject and care giver when using the NPWT system
Measured: maximum 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Non Infected 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Bischoff, Prof. Dr. med, Principal investigator, Ulm University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195896
- Sponsor's protocol ID
- NPWT 02
- Status last verified
- Jan 2012
- First submitted
- 3 Sep 2010
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds.
- ClinicalTrials.gov ID
- NCT01195896
- Acronym / sponsor ID
- NPWT 02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Sep 2010 (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 investigation is designed as a prospective, open, non-controlled clinical investigation.
Detailed description
Wounds to be treated under this protocol should be acute non-infected wounds or post surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for a maximum duration of 3 weeks. All subjects will receive continuous negative pressure treatment with the new NPWT system with a pressure level of -120 mmHg or according to clinicians' instruction based on the indication.
10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and who have signed and dated a written informed consent.
The subjects will be consecutively allocated to a specific subject identification code. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.
Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of wound infections according to clinical routine.
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 (4 listed)
- Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- 3 cm2 ≤ Wound size ≤ 300 cm2
- Male or female ≥18 years
- Signed Informed Consent Form
Key exclusion criteria (18 listed)
- Need for frequent dressing changes, i.e.<48 hours between the changes
- Dry wounds
- Malignancy in the wound and/or wound margin
- Untreated osteomyelitis
- Untreated infection waiting for other intervention
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 |
|---|---|---|
| New NPWT systemAccording clinical routine (Instruction for Use) | Device | – |
Primary outcome
Granulation tissue formation
Time frame: maximum 3 weeks
To assess the wound healing and granulation tissue formation when using the NPWT system
1 secondary outcome
Handling of NPWT system
Time frame: maximum 3 weeks
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 16 Jan 2012.
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.
Mark Bischoff, Prof. Dr. med principal investigator
Ulm University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New NPWT system in people with Acute Non Infected Wounds and Non Infected Post Surgical Wounds, run by Molnlycke Health Care AB at 1 site in Germany.
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 18 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 16 Jan 2012. 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 Germany. 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 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?
Granulation tissue formation (time frame: maximum 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 16 Jan 2012.