Trial Outcomes & Findings for Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation (NCT NCT01939145)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

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

Results posted on

2016-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Normal Saline The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation. 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	Prontosan The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation. 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.
Overall Study STARTED	49	51
Overall Study COMPLETED	47	44
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Saline n=49 Participants The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation. 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	Prontosan n=51 Participants The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation. 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.	Total n=100 Participants Total of all reporting groups
Age, Continuous	59.64 years STANDARD_DEVIATION 15.4 • n=5 Participants	55.94 years STANDARD_DEVIATION 13.9 • n=7 Participants	58.37 years STANDARD_DEVIATION 14.09 • n=5 Participants
Gender Female	21 Participants n=5 Participants	8 Participants n=7 Participants	29 Participants n=5 Participants
Gender Male	28 Participants n=5 Participants	43 Participants n=7 Participants	71 Participants n=5 Participants
Race/Ethnicity, Customized African America	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Missing/declined	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normal Saline n=49 Participants The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation. 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	Prontosan n=51 Participants The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation. 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.
Number of Operating Room Visits	2.5 Operative Room Visits Standard Deviation 0.9	2.8 Operative Room Visits Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normal Saline n=49 Participants The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation. 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	Prontosan n=51 Participants The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation. 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.
Hospital Admission Length of Stay	13.6 days Standard Deviation 11.7	14.5 days Standard Deviation 9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Normal Saline

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Prontosan

Serious events: 3 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Normal Saline n=49 participants at risk The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation. 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	Prontosan n=51 participants at risk The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation. 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.
Surgical and medical procedures Amputation	2.0% 1/49 • Number of events 1	5.9% 3/51 • Number of events 3
Cardiac disorders Death	2.0% 1/49 • Number of events 1	3.9% 2/51 • Number of events 2

Other adverse events

Other adverse events
Measure	Normal Saline n=49 participants at risk The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation. 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	Prontosan n=51 participants at risk The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation. 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.
Infections and infestations Infection	16.3% 8/49 • Number of events 9	17.6% 9/51 • Number of events 10
Surgical and medical procedures Wound dehiscence	12.2% 6/49 • Number of events 7	27.5% 14/51 • Number of events 19

Additional Information

Paul J. Kim, DPM, Director of Research

MGUH Center for Wound Healing and Hyperbaric Medicine

Phone: 202-444-3059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place