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

NCT01939145 | Completed Phase 4 Results

• 1 other identifier: 06142013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Infection

Keywords

hospital admission

Outcome Measures

Primary Outcomes (1)

• Number of Operating Room Visits

  Compare the number of operative room visits between Prontosan NPWTi and normal saline NPWTi.

  Patients will be followed during their hospital stay which is an average of approximately 2 weeks.

Secondary Outcomes (1)

• Hospital Admission Length of Stay

  Patients will be followed during their hospital stay which is an average of approximately 2 weeks.

Other Outcomes (3)

• Time to Closure

  Patients will be followed during their hospital stay which is an average of approximately 2 weeks.

• Wound Recidivism

  30 days post discharge from hospital

• Bacterial Culture Results

  Patients will be followed during their hospital stay which is an average of approximately 2 weeks.

Study Arms (2)

Normal Saline

ACTIVE COMPARATOR

The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.

Drug: Normal saline

Prontosan

ACTIVE COMPARATOR

The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.

Device: Prontosan

Interventions

Normal saline DRUG

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

Also known as: 0.9% Saline

Normal Saline

Prontosan DEVICE

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.

Also known as: Prontosan Wound Irrigation Solution

Prontosan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Medstar Georgetown University Hospital Center for Wound Healing

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Paul J. Kim, DPM, Director of Research
• Organization: MGUH Center for Wound Healing and Hyperbaric Medicine

Paul.J.Kim@gunet.georgetown.edu

202-444-3059

Study Officials

• Paul Kim, DPM

  MedStar Georgetown University Hospital

  STUDY DIRECTOR

• Christopher Attinger, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

• John Steinberg, DPM

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

• Karen Evans, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 11, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: December 29, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)