WoundsNCT01191567
Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
A study testing VAC treatment and Conventional treatment in people with Wounds, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Wounds have long been a source of suffering for unfortunate victims and in recent years new complementary methods have been developed in areas where traditional wound treatment has been insufficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- VAC treatment and Conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Jul 2012
- 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 wounds with substance defect after primary suture demanding further treatment or wounds not primary sutured
- wounds with osteosynthesis, bone or tendon visual regardless wound size
- postoperative infections with wound and substance defect demanding further treatment.
- fasciotomy on extremity
Who cannot join
- wound size < 2 cm and depth < 1 cm
- pressure ulcers, open abdomen and chronic ulcers
- patients with dementia or mental illness so severe that participation in the study is impossible
- patients non in command of the swedish language
- ongoing treatment with warfarin
Trial locations and contacts
1 site in 1 country.
About this study
Wounds have long been a source of suffering for unfortunate victims and in recent years new complementary methods have been developed in areas where traditional wound treatment has been insufficient. Treating wounds with negative pressure, Vacuum assisted closure® [VAC], is a relatively new method of treatment and knowledge about its effect on patients is limited.
Earlier studies haven't been able to answer the question about which groups of patients that are in most favour of the treatment and what impact the treatment has on the patient's quality of life.
Read more
It is important with further research since an effective and mild wound treatment can decrease suffering and increase quality of life for the patient. Wound treatment that does not lead to an achieved treatment goal can lead to a risk for the patient and should be avoided.
The project consists of 4 part studies: Study 1 and 2 are chart review studies of a consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period. The patients are described on the basis of medical, surgical and demographical factors. Outcome is treatment results and risk factors for a treatment failure.
Study 3 and 4 are clinical randomised studies with the aim of studying whether treatment with VAC provides a faster and more effective healing of acute and postoperative wounds, and in what way the treatment affect the quality of life and pain of the patients, compared to conventional treatment.
- Conditions
- Wounds
- Being tested
- VAC treatment, Conventional treatment
- Keywords
- acute wounds, postoperative wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC treatmentProcedure or surgery
wound treatment with VAC-therapy
Conventional treatmentProcedure or surgery
wound treatment with conventional treatment according to the hospitals local routines
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Not described Receives: Procedure: Conventional treatment |
| VAC treatment | Experimental | Not described Receives: Procedure: VAC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment results
successfully treated or non-successfully treated
Measured: 2 weeks
wound size
meassured with Visitrak
Measured: 2 weeks
Quality of life
meassured with EQ-5D form and a diary with content analysis
Measured: 2 weeks
Secondary outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 2 weeks
costs for treatment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: insufficient recruitement speed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Ann-Mari Wallin, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191567
- Sponsor's protocol ID
- 2008/2023-31
- Status last verified
- Nov 2017
- First submitted
- 26 Aug 2010
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
- ClinicalTrials.gov ID
- NCT01191567
- Acronym / sponsor ID
- 2008/2023-31
- Conditions
- Wounds
- Keywords
- acute wounds, postoperative wounds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitement speed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Aug 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.
Wounds have long been a source of suffering for unfortunate victims and in recent years new complementary methods have been developed in areas where traditional wound treatment has been insufficient. Treating wounds with negative pressure, Vacuum assisted closure® [VAC], is a relatively new method of treatment and knowledge about its effect on patients is limited.
Earlier studies haven't been able to answer the question about which groups of patients that are in most favour of the treatment and what impact the treatment has on the patient's quality of life.
It is important with further research since an effective and mild wound treatment can decrease suffering and increase quality of life for the patient. Wound treatment that does not lead to an achieved treatment goal can lead to a risk for the patient and should be avoided.
The project consists of 4 part studies: Study 1 and 2 are chart review studies of a consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period. The patients are described on the basis of medical, surgical and demographical factors. Outcome is treatment results and risk factors for a treatment failure.
Study 3 and 4 are clinical randomised studies with the aim of studying whether treatment with VAC provides a faster and more effective healing of acute and postoperative wounds, and in what way the treatment affect the quality of life and pain of the patients, compared to conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Procedure: Conventional treatment |
| VAC treatment | Experimental | Procedure: VAC treatment |
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 wounds with substance defect after primary suture demanding further treatment or wounds not primary sutured
- wounds with osteosynthesis, bone or tendon visual regardless wound size
- postoperative infections with wound and substance defect demanding further treatment.
- fasciotomy on extremity
Key exclusion criteria (5 listed)
- wound size < 2 cm and depth < 1 cm
- pressure ulcers, open abdomen and chronic ulcers
- patients with dementia or mental illness so severe that participation in the study is impossible
- patients non in command of the swedish language
- ongoing treatment with warfarin
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 |
|---|---|---|
| VAC treatmentwound treatment with VAC-therapy | Procedure or surgery | VAC treatment |
| Conventional treatmentwound treatment with conventional treatment according to the hospitals local routines | Procedure or surgery | Conventional treatment |
Primary outcome
treatment results
Time frame: 2 weeks
successfully treated or non-successfully treated
wound size
Time frame: 2 weeks
meassured with Visitrak
Quality of life
Time frame: 2 weeks
meassured with EQ-5D form and a diary with content analysis
2 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 weeks
costs for treatment
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: insufficient recruitement speed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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 VAC treatment and Conventional treatment in people with Wounds, run by Karolinska Institutet at 1 site 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Nov 2017. 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 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.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitement speed). Results are not available in the source record.
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?
treatment results (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 17 Nov 2017.