Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
Primary Purpose
Wounds
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
VAC treatment
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring acute wounds, postoperative wounds
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
Sites / Locations
- Södersjukhuset
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional treatment
VAC treatment
Arm Description
Outcomes
Primary Outcome Measures
treatment results
successfully treated or non-successfully treated
wound size
meassured with Visitrak
Quality of life
meassured with EQ-5D form and a diary with content analysis
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
costs for treatment
Full Information
NCT ID
NCT01191567
First Posted
August 26, 2010
Last Updated
November 15, 2017
Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01191567
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitement speed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
acute wounds, postoperative wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Title
VAC treatment
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
VAC treatment
Intervention Description
wound treatment with VAC-therapy
Intervention Type
Procedure
Intervention Name(s)
Conventional treatment
Intervention Description
wound treatment with conventional treatment according to the hospitals local routines
Primary Outcome Measure Information:
Title
treatment results
Description
successfully treated or non-successfully treated
Time Frame
2 weeks
Title
wound size
Description
meassured with Visitrak
Time Frame
2 weeks
Title
Quality of life
Description
meassured with EQ-5D form and a diary with content analysis
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
2 weeks
Title
costs for treatment
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
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