Clinical trial NCT01191567: Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
Official title: Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wounds
Keywords: acute wounds
postoperative wounds
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
First posted: 2010-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: treatment results
timeFrame: 2 weeks
measure: wound size
timeFrame: 2 weeks
measure: Quality of life
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 2 weeks
measure: costs for treatment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
References: