Trial Outcomes & Findings for VAC Bioburden Wound Care Assessment (NCT NCT04826965)
NCT ID: NCT04826965
Last Updated: 2023-11-03
Results Overview
Bacterial bio-burden as measured by microbial PCR prior to debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (\< 1x10\^5), medium (1x10\^5 to 1x10\^7), and high (\> 1x10\^7) counts of bacteria per gram.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Day 1 (day of first operative debridement)
Results posted on
2023-11-03
Participant Flow
Participant milestones
| Measure |
Wound Vac Application
Wound vac application for open upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
Wound Vac Application Including Irrigation
Wound vac application WITH irrigation for upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VAC Bioburden Wound Care Assessment
Baseline characteristics by cohort
| Measure |
Wound Vac Application
n=3 Participants
Wound vac application for open upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
Wound Vac Application Including Irrigation
n=2 Participants
Wound vac application WITH irrigation for upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 (day of first operative debridement)Bacterial bio-burden as measured by microbial PCR prior to debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (\< 1x10\^5), medium (1x10\^5 to 1x10\^7), and high (\> 1x10\^7) counts of bacteria per gram.
Outcome measures
| Measure |
Wound Vac Application
n=3 Participants
Wound vac application for open upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
Wound Vac Application Including Irrigation
n=2 Participants
Wound vac application WITH irrigation for upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
|---|---|---|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement
Low
|
0 Participants
|
0 Participants
|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement
Medium
|
1 Participants
|
1 Participants
|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement
High
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 (day of first operative debridement)Bacterial bio-burden as measured by microbial PCR after debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (\< 1x10\^5), medium (1x10\^5 to 1x10\^7), and high (\> 1x10\^7) counts of bacteria per gram.
Outcome measures
| Measure |
Wound Vac Application
n=3 Participants
Wound vac application for open upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
Wound Vac Application Including Irrigation
n=2 Participants
Wound vac application WITH irrigation for upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
|---|---|---|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement
Low
|
1 Participants
|
1 Participants
|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement
Medium
|
1 Participants
|
1 Participants
|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement
High
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 2 (day of second operative debridement)Bacterial bio-burden as measured by microbial PCR prior to debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (\< 1x10\^5), medium (1x10\^5 to 1x10\^7), and high (\> 1x10\^7) counts of bacteria per gram.
Outcome measures
| Measure |
Wound Vac Application
n=3 Participants
Wound vac application for open upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
Wound Vac Application Including Irrigation
n=2 Participants
Wound vac application WITH irrigation for upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
|
|---|---|---|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement
Low
|
1 Participants
|
1 Participants
|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement
Medium
|
1 Participants
|
0 Participants
|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement
High
|
0 Participants
|
1 Participants
|
|
Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement
Not Detected
|
1 Participants
|
0 Participants
|
Adverse Events
Wound Vac Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wound Vac Application Including Irrigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place