Overview

This trial is active, not recruiting.

Conditions trauma-related wound, surgical wound, recent
Treatment snap® wound care system
Sponsor Spiracur, Inc.
Start date June 2011
End date February 2013
Trial size 30 participants
Trial identifier NCT01417234, 102110

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
snap® wound care system
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Primary Outcomes

Measure
Wound Closure
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Spiracur, Inc..