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

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2016

Conditions
Wound Infection
Interventions
DRUG

Normal saline

Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies

DEVICE

Prontosan

Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies.

Trial Locations (1)

20007

Medstar Georgetown University Hospital Center for Wound Healing, Washington D.C.

All Listed Sponsors
lead

Georgetown University

OTHER

NCT01939145 - Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation | Biotech Hunter | Biotech Hunter