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

3M Company

Status: Completed

Conditions: Surgical Wound, Recent; Trauma-related Wound

Treatments: Device: SNaP® Wound Care System

Study type: Observational

Funder types: Industry

Identifiers

NCT01417234

102110

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

SNaP® Wound Care System

Treatment:

Device: SNaP® Wound Care System