A Prospective, Randomized, Multi-Center Trial Evaluating the Effectiveness of the V.A.C.Ulta(TM) Negative Pressure Wound Therapy System with V.A.C. VeraFlo(TM) Dressing System in Operatively Debrided Wounds

Study ID
STU 052013-065

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital—St. Paul
  • Parkland Health & Hospital System

Contact
Thanalakshmi Seenivasan
214-648-9015
thanalakshmi.seenivasan@utsouthwestern.edu

Principal Investigator
Lawrence Lavery

Summary

This protocol outlines a prospective, randomized, multi-center, human subject trial comparing the V.a.C.ulta[TM] Therapy System with and without instillation in wounds that require operative debridement. after operative debridement and assessment of appropriateness for nPWT, patients will be randomized into either the V.a.C. ulla[TM] without instillation (Control) arm or the V.a.C. ulla[TM] with instillation (Treatment) arm. Subjects will receive assigned study therapy until the investigator deems the wound ready for closure or coverage. investigators will follow, evaluate and make clinical decisions regarding wound therapy, further debridement, or readiness for closure.

Participant Eligibility

The Subject:
1. has a wound prior to informed consent

2. will be admitted as an inpatient

3. is >: 18 years of age at time of consent

4. is able to provide his/her own informed consent

5. is willing and able to return for all scheduled and required study visits

6. has an open wound ::: 4 cm in any plane of measurement excluding tunnels

7. has a wound that is appropriate for NPWT according to approved indications for use

8. has not participated in a clinical trial within the past 30 days.

9. has a 30 day wound history available if the wound has been previously treated