NCT02009501

V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds

A Prospective, Open, Comparative, Randomized Single-center Study to Evaluate the Effect of V.A.C. VeraFlo™ Therapy With .125% Dakins vs V.A.C. Ulta™ Therapy on Biofilm Removal/Disruption/Elimination in Chronically Infected Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: St. Luke's-Roosevelt Hospital Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.

Conditions

• Lower Extremity Wound Infected
• Venous Stasis Ulcers

Interventions

Type	Name	Description
DEVICE	VAC VeraFlo with Dakins Instillation	VAC VeraFlo with Dakins instillation will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
DEVICE	VAC Ulta Therapy	VAC ULTA will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2013-12-12
• Last updated: 2018-11-27
• Results posted: 2018-11-27

Locations

1 site across 1 country: United States