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

Wound Infection Clinical Trial

Official title:

A Prospective Randomized Trial Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01939145
• Other study ID #: 06142013
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 3, 2013
• Last updated: February 8, 2016
• Start date: September 2013
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Overview This is a prospective, randomized, comparative trial examining 2 different instillation solutions for NPWTi. All wound types that meet the eligibility criteria will be enrolled into the study. After enrollment, subjects will be randomized into either the Prontosan NPWTi group (n=50) or the normal saline NPWTi group (n=50). Data will be collected from inpatient hospital records.

Outline of Study Procedures

1. Patients meeting the eligibility criteria requiring hospital admission for an infected wound will be identified. Demographic information will be obtained.

2. Informed consent will be obtained.

3. Subjects will be taken to the operating room for wound debridement within 72 hours of admission per standard of care (SOC). Further, antibiotic therapy and medical management will be performed per SOC.

4. Randomization into the Prontosan or normal saline instillation group will be conducted after the informed consent has been signed, but before the first operation.

5. For the first operating room visit the following will be conducted:

1. Pre- and post debridement qualitative cultures

2. Debridement performed in SOC fashion

3. Post debridement measurements

4. Application of NPWTi

6. For subsequent operating room visits the following will be conducted:

a. Pre- and post debridement qualitative cultures b. Debridement performed in SOC fashion c. Post debridement measurements d. Application of NPWTi or closure i. The decision to close the wound will be determined by the clinician per SOC.

ii. The technique utilized for closure will be determined by the clinician per SOC.

7. Subjects will discharged from the hospital

a. Criteria for discharge will be per the judgment of the investigator per SOC

8. After hospital discharge, the subject will be followed in the outpatient wound clinic per SOC. Information from the one month follow-up period will be collected. Subjects will be exited from the study at that point.

Subject Recruitment No active recruitment strategy will be employed. Patients who meet the eligibility criteria will be approached to participate into the study.

Participation Completion and Discontinuation:

Subjects may elect to discontinue participation at any time for any reason. Investigators may elect to remove the subject from participating at any time for any reason.

Surgical Technique:

Surgical debridement will be performed in SOC manner and is at the discretion of the investigator.

Postoperative Care:

Will be conducted in customary SOC fashion and is at the discretion of the investigator. The 30 day follow-up visit is part of SOC

Application of Devices/Dressing:

The device that will be utilized is the V.A.C. Ulta with Veraflo Technology (Kinetic Concepts Inc., San Antonio, TX). This is an FDA approved device that is indicated for wound care. The investigators currently use this device as the SOC for the inpatient management of the acutely infected wound. The device consists of a foam sponge applied to the wound surface with an adhesive drape that keeps it in place. This device applies subatmospheric pressure at -125mmHg to the wound surface. The instillation component includes the delivery of a topical solution at prescribed fashion to the wound surface. This solution is dwelled (no negative pressure during this interval) in the sponge for a specific duration and then is evacuated.

Negative Pressure Wound Therapy:

The setting for negative pressure will be -125mmHg, continuous setting, and moderate intensity. The application of the foam and drape will be conducted in the customary fashion. The negative pressure duration will be 2 hours.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Medstar Georgetown University Hospital Center for Wound Healing	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Closure	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.	Patients will be followed during their hospital stay which is an average of approximately 2 weeks.	No
Other	Wound Recidivism	Compare the percent of wounds that remained closed 30 days and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.	30 days post discharge from hospital	No
Other	Bacterial Culture Results	Compare the qualitative bacterial culture results between Prontosan NPWTi and normal saline NPWTi.	Patients will be followed during their hospital stay which is an average of approximately 2 weeks.	No
Primary	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.	No
Secondary	Hospital Admission Length of Stay	Compare the hospital admission length of stay between Prontosan NPWTi and normal saline NPWTi.	Patients will be followed during their hospital stay which is an average of approximately 2 weeks.	No