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

NCT ID: NCT01191567

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Wounds

Keywords

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acute wounds postoperative wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional treatment

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type PROCEDURE

wound treatment with conventional treatment according to the hospitals local routines

VAC treatment

Group Type EXPERIMENTAL

VAC treatment

Intervention Type PROCEDURE

wound treatment with VAC-therapy

Interventions

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VAC treatment

wound treatment with VAC-therapy

Intervention Type PROCEDURE

Conventional treatment

wound treatment with conventional treatment according to the hospitals local routines

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Ann-Mari Wallin

RN, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Södersjukhuset

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008/2023-31

Identifier Type: -

Identifier Source: org_study_id