N/A
Completed N=30
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Trauma-related Wound · Surgical Wound, Recent
Source: ClinicalTrials.gov NCT01417234 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Wound Closure — 22 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Closure |
22 | — |
| SECONDARY Percent Wound Size Change |
-3.6 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01417234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.