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

NCT01191567 | Terminated DMC

• 1 other identifier: 2008/2023-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

acute wounds; postoperative wounds

Outcome Measures

Primary Outcomes (3)

• treatment results

  successfully treated or non-successfully treated

  2 weeks

• wound size

  meassured with Visitrak

  2 weeks

• Quality of life

  meassured with EQ-5D form and a diary with content analysis

  2 weeks

Secondary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2 weeks

• costs for treatment

  2 weeks

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Procedure: Conventional treatment

VAC treatment

EXPERIMENTAL

Procedure: VAC treatment

Interventions

VAC treatment PROCEDURE

wound treatment with VAC-therapy

VAC treatment

Conventional treatment PROCEDURE

wound treatment with conventional treatment according to the hospitals local routines

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm South General Hospital: collaborator

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 31, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

SE (1)