Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.

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Detailed Description

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Conditions

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Trauma-related Wound Surgical Wound, Recent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SNaP® Wound Care System

Intervention Type DEVICE

Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Interventions

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SNaP® Wound Care System

Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
* Wound \< 16 cm in greatest diameter
* Subject ≥ 18 years of age
* Exudate \< 25 ml/ day (estimate)
* Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
* Subject is willing and able to sign informed consent

Exclusion Criteria

* Wound \> 45 days old
* Wound-related cellulitis
* Wound located in an area not amenable to forming an air-tight seal
* Subject has untreated osteomyelitis
* Subject is allergic to wound care products
* Wound has exposed blood vessels not suitable for negative pressure therapy
* Subject is pregnant
* Subject is actively participating in other clinical trials that conflict with current study
* Subject has fistulas

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No