Simplified Negative Pressure Wound Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-02-29

Brief Summary

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The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.

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Detailed Description

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Conditions

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Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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simplified Negative Pressure Wound Therapy

The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria.

Group Type EXPERIMENTAL

simplified negative pressure wound therapy device (Wound Pump device)

Intervention Type DEVICE

A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.

Interventions

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simplified negative pressure wound therapy device (Wound Pump device)

A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.

Intervention Type DEVICE

Other Intervention Names

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Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.

Eligibility Criteria

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Inclusion Criteria

* open wound appropriate for NPWT
* wound size greater than 2 cm2 and less than 150 cm2
* adequate adjacent intact skin for application of sNPWT
* adequate contour of wound location for application of sNPWT
* patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
* the patient is expected to remain clinically stable for the duration of the study
* the patient is to remain hospitalized for the duration of the study
* patient or their legal representative is willing and able to sign an IRB-approved informed consent
* patient less than 21 years old is willing to sign an approved assent form if able to sign

Exclusion Criteria

* exposed blood vessels
* ischemic wound
* wound with necrotic tissue requiring further debridement at the time of enrollment
* infection
* acute osteomyelitis
* malignancy in the wound
* latex or rubber containing product sensitivity

Minimum Eligible Age

14 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No