Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | July 2016 |
A Prospective Randomized Trial Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
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.
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.
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.
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.
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
We found this trial at
1
site
Washington, District of Columbia 20007
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