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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01191567
• Other study ID #: 2008/2023-31
• Status: Terminated
• Phase: N/A
• First received: August 26, 2010
• Last updated: November 15, 2017
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds
• Wounds and Injuries

Intervention

Procedure:
• VAC treatment
wound treatment with VAC-therapy
• Conventional treatment
wound treatment with conventional treatment according to the hospitals local routines

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment results	successfully treated or non-successfully treated	2 weeks
Primary	wound size	meassured with Visitrak	2 weeks
Primary	Quality of life	meassured with EQ-5D form and a diary with content analysis	2 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		2 weeks
Secondary	costs for treatment		2 weeks