Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized trial comparing the outcomes for Prontosan versus normal saline as the solution for negative pressure wound therapy with instillation (NWPTi). Negative pressure wound therapy (NPWT) is a well established method of treatment for acute and chronic wounds. The combination of negative pressure with instillation of a solution is a relatively novel concept that has gained popularity and is currently used nationally and internationally. NPWTi is the standard of care for our division. Despite the growing use, there is limited information regarding the selection of the ideal instillation solution. This is a single site, investigator initiated, NPWTi study comparing the use of Prontosan with normal saline for the adjunctive treatment of the acutely infected wound that requires hospital admission. A total of 100 subjects will be included with 50 subjects in each treatment arm. The outcomes that will be measured are 1) number of operations, 2) length of hospital stay, 3) % of wounds closed prior to discharge, 4) time to closure prior to discharge, 5)% remained closed at 30 day follow-up, and 6) reduction of qualitative bacterial cultures. The results from this study will better characterize the most appropriate use of NPWTi.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Male or female greater than 18 years of age

• Admission to the hospital for an infected wound

• Diabetic, ischemic, neuropathic, venous, surgical wounds, any anatomical location

• Subjects requiring serial (more than 1) operative debridement

Exclusion Criteria:

• Pregnancy

• Patients with exposed bowel, brain matter, spinal cord

• Patients with exposed peripheral bypass grafts

• Known allergy or sensitivity to Prontosan or components of NPWT

• Known allergy or sensitivity to adhesives

• Uncontrolled bleeding disorders/coagulopathy

• Wounds that tunnel to unexposed areas

• Malignancy