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Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life

This study has been terminated.
(insufficient recruitement speed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191567
First Posted: August 31, 2010
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stockholm South General Hospital
Information provided by (Responsible Party):
Ann-Mari Wallin, Karolinska Institutet
  Purpose

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 Intervention
Wounds Procedure: VAC treatment Procedure: Conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life

Resource links provided by NLM:


Further study details as provided by Ann-Mari Wallin, Karolinska Institutet:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 weeks ]
  • costs for treatment [ Time Frame: 2 weeks ]

Enrollment: 30
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Sweden
Södersjukhuset
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
Stockholm South General Hospital
  More Information

Responsible Party: Ann-Mari Wallin, RN, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01191567     History of Changes
Other Study ID Numbers: 2008/2023-31
First Submitted: August 26, 2010
First Posted: August 31, 2010
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Ann-Mari Wallin, Karolinska Institutet:
acute wounds
postoperative wounds

Additional relevant MeSH terms:
Wounds and Injuries