Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
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|ClinicalTrials.gov Identifier: NCT01191567|
Recruitment Status : Terminated (insufficient recruitement speed)
First Posted : August 31, 2010
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Wounds||Procedure: VAC treatment Procedure: Conventional treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Active Comparator: Conventional treatment||
Procedure: Conventional treatment
wound treatment with conventional treatment according to the hospitals local routines
|Experimental: VAC treatment||
Procedure: VAC treatment
wound treatment with VAC-therapy
- 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
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 weeks ]
- costs for treatment [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191567
|Stockholm, Sweden, 11883|