Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2011 |
| Contact: | Michele Loor, MD |
| Email: | loorm@ccf.org |
| Phone: | 216-444-0733 |
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.
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
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