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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Karolinska Institutet
Sponsor:
Collaborator:
Stockholm South General Hospital
Information provided by (Responsible Party):
Ann-Mari Wallin, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01191567
First received: August 26, 2010
Last updated: May 27, 2014
Last verified: May 2014
  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
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

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Primary Completion Date: January 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191567

Contacts
Contact: Ann-Mari Wallin, RN +46 8 616 24 15 ann-mari.wallin@sodersjukhuset.se

Locations
Sweden
Södersjukhuset Recruiting
Stockholm, Sweden, 11883
Contact: Ann-Mari Fagerdahl, RN, PhD    +46 8 616 24 15    ann-mari.fagerdahl@sodersjukhuset.se   
Principal Investigator: Ann-Mari Wallin, RN         
Sponsors and Collaborators
Karolinska Institutet
Stockholm South General Hospital
  More Information

No publications provided

Responsible Party: Ann-Mari Wallin, RN, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01191567     History of Changes
Other Study ID Numbers: 2008/2023-31
Study First Received: August 26, 2010
Last Updated: May 27, 2014
Health Authority: Sweden: Institutional Review Board

Keywords provided by Karolinska Institutet:
acute wounds
postoperative wounds

ClinicalTrials.gov processed this record on August 27, 2014