Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
This trial is active, not recruiting.
|Conditions||trauma-related wound, surgical wound, recent|
|Treatment||snap® wound care system|
|Start date||June 2011|
|End date||February 2013|
|Trial size||30 participants|
|Trial identifier||NCT01417234, 102110|
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.
time frame: 12 weeks
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
|Official title||Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds|
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