Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
Recruitment status was: Recruiting
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life|
- treatment results [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]successfully treated or non-successfully treated
- wound size [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]meassured with Visitrak
- Quality of life [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- costs for treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191567
|Stockholm, Sweden, 11883|