Trial Outcomes & Findings for Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds (NCT NCT03722485)
NCT ID: NCT03722485
Last Updated: 2024-10-16
Results Overview
The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
baseline and 6-9 days of treatment
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
25
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
subject discharged prior to study completion
|
1
|
5
|
|
Overall Study
eligibility criteria not met
|
2
|
0
|
Baseline Characteristics
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds
Baseline characteristics by cohort
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
n=13 Participants
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
n=16 Participants
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 14.02 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 12.97 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Wound Type
Pressure Ulcer
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Wound Type
Venous leg ulcer
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Wound Type
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 6-9 days of treatmentPopulation: Modified ITT population
The Absolute Change in the Percentage of Wound bed surface area (cm2) considered to be clean, healthy, and viable from baseline to Day 6-9 upon the final dressing removal.
Outcome measures
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
n=13 Participants
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
n=16 Participants
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
Absolute Change in the Percentage of Wound Bed Surface Area (%) Considered Clean, Healthy and Viable From Baseline to Day 6-9 Upon Dressing Removal.
|
27.9 percent wound clean healthy viable.
Standard Deviation 34.35
|
11.6 percent wound clean healthy viable.
Standard Deviation 40.52
|
SECONDARY outcome
Timeframe: baseline and 6-9 days of treatmentPopulation: Modified ITT population
The percent change in total wound volume (%) from baseline to Day 6-9 upon the final dressing removal.
Outcome measures
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
n=13 Participants
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
n=16 Participants
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
Percent Change in Total Wound Volume (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
|
-0.3 percent change in wound volume
Standard Deviation 0.59
|
1.3 percent change in wound volume
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: baseline and 6-9 days of treatmentPopulation: Modified ITT population
The percent change in total wound area (%) from baseline to Day 6-9 upon the final dressing removal.
Outcome measures
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
n=13 Participants
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
n=16 Participants
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
Percent Change in Total Wound Area (%) From Baseline to Day 6-9 Upon the Final Dressing Removal.
|
0 percent change in wound area
Standard Deviation 0.20
|
0.1 percent change in wound area
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: 6-9 days of treatmentPopulation: Modified ITT population
Physician assessment of the need for surgical debridement upon completion of study treatment up to Day 6-9.
Outcome measures
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
n=13 Participants
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
n=16 Participants
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
Physician Assessment of Need for Wound Debridement
Not needing debridement
|
3 Participants
|
2 Participants
|
|
Physician Assessment of Need for Wound Debridement
Yes, needing debridement
|
10 Participants
|
14 Participants
|
Adverse Events
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Collagenase Ointment
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
n=17 participants at risk
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
n=25 participants at risk
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
General disorders
impaired healing
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Infections and infestations
sepsis
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Injury, poisoning and procedural complications
post-procedural hemorrhage
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
Other adverse events
| Measure |
Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d)
n=17 participants at risk
V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution
Negative Pressure Therapy w/ instillation and dwell (NPWTi-d): Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
|
Collagenase Ointment
n=25 participants at risk
Collagenase Ointment
Collagenase Ointment: Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
|
|---|---|---|
|
Cardiac disorders
fluid overload
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Gastrointestinal disorders
gastro-intestinal hemorrhage
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Gastrointestinal disorders
nausea
|
11.8%
2/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
General disorders
pyrexia
|
11.8%
2/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Investigations
blood potassium increase
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Investigations
hemoglobin decrease
|
23.5%
4/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
5.9%
1/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
0.00%
0/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Vascular disorders
hypotension
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
8.0%
2/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Blood and lymphatic system disorders
splenic infarction
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Eye disorders
conjunctivitis
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Gastrointestinal disorders
epi-gastric discomfort
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
General disorders
lethargy
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
General disorders
mucosal hypertrophy
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
General disorders
pain
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Infections and infestations
candida infection
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Infections and infestations
osteomyelitis
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Infections and infestations
wound infection
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
8.0%
2/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Investigations
blood glucose decreased
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Investigations
white blood cell count increased
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Metabolism and nutrition disorders
hyper natremia
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Product Issues
device occlusion
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
|
Renal and urinary disorders
incontinence
|
0.00%
0/17 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
4.0%
1/25 • Up to the last study visit, which was labeled as being the 6 to 9-day visit
The safety set consisted of 17 subjects in the Negative Pressure Therapy w/ Instillation and Dwell (NPWTi-d) group/arm and not 19 subjects (the total randomized to this group/arm) because two subjects were deemed to not meet eligibility criteria post-randomization and did to not receive treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place