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

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ClinicalTrials.gov Identifier: NCT01939145
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : February 8, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Paul J. Kim, DPM, Georgetown University

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.

Condition or disease Intervention/treatment Phase
Wound Infection Drug: Normal saline Device: Prontosan Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
Study Start Date : September 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Normal Saline
The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.
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
Other Name: 0.9% Saline

Active Comparator: Prontosan
The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.
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.
Other Name: Prontosan Wound Irrigation Solution




Primary Outcome Measures :
  1. Number of Operating Room Visits [ Time Frame: Patients will be followed during their hospital stay which is an average of approximately 2 weeks. ]
    Compare the number of operative room visits between Prontosan NPWTi and normal saline NPWTi.


Secondary Outcome Measures :
  1. Hospital Admission Length of Stay [ Time Frame: Patients will be followed during their hospital stay which is an average of approximately 2 weeks. ]
    Compare the hospital admission length of stay between Prontosan NPWTi and normal saline NPWTi.


Other Outcome Measures:
  1. Time to Closure [ Time Frame: Patients will be followed during their hospital stay which is an average of approximately 2 weeks. ]
    Compare the percent of wounds closed and the time to closure during the hospital admission and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.

  2. Wound Recidivism [ Time Frame: 30 days post discharge from hospital ]
    Compare the percent of wounds that remained closed 30 days and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.

  3. Bacterial Culture Results [ Time Frame: Patients will be followed during their hospital stay which is an average of approximately 2 weeks. ]
    Compare the qualitative bacterial culture results between Prontosan NPWTi and normal saline NPWTi.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939145


Locations
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United States, District of Columbia
Medstar Georgetown University Hospital Center for Wound Healing
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
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Study Director: Paul Kim, DPM MedStar Georgetown University Hospital
Principal Investigator: 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

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Responsible Party: Paul J. Kim, DPM, Principal Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT01939145     History of Changes
Other Study ID Numbers: 06142013
First Posted: September 11, 2013    Key Record Dates
Results First Posted: February 8, 2016
Last Update Posted: December 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data collected has not been approved for use beyond the scope of this trial and will not be made available.

Keywords provided by Paul J. Kim, DPM, Georgetown University:
hospital admission

Additional relevant MeSH terms:
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Wound Infection
Wounds and Injuries
Infection
Pharmaceutical Solutions