Skip to main content
OpenTrials
Completed

NCT Number: NCT01417234

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Trauma-related Wound Surgical Wound Surgical Wound, Recent Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 41955, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SNaP® Wound Care System

Device

Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Primary outcomes

  1. Wound Closure

    Time frame: 12 weeks

    Percent of subjects with study wound deemed closed at 12 weeks

    1 wound is studied per participant

Secondary outcomes

  1. Percent Wound Size Change

    Time frame: Baseline and 4 weeks

    Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline)

  2. Percent Wound Size Change

    Time frame: 4 weeks and 8 weeks

    Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4)

  3. Percent Wound Size Change

    Time frame: 8 weeks and 12 weeks

    Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks)

Sponsors and collaborators

Lead sponsor

3M

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 16, 2011
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.