Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
Condition: Wound Infection
MeSH terms: Wound Infection; Wounds and Injuries
Intervention: Normal saline; Prontosan
Intervention description: 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; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hospital admission

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.
    

Eligibility 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