Trial Outcomes & Findings for Enhancement of Pressure Healing With Pulsatile Lavage (NCT NCT00047619)
NCT ID: NCT00047619
Last Updated: 2015-10-05
Results Overview
Linear assessment of wounds
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
study participation - up to 6 weeks
Results posted on
2015-10-05
Participant Flow
Participant milestones
| Measure |
Pulsatile Lavage Group
pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed
|
Sham Lavage Group
sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage to not directed at wound or patient
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancement of Pressure Healing With Pulsatile Lavage
Baseline characteristics by cohort
| Measure |
Pulsatile Lavage Group
n=14 Participants
pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed
|
Sham Lavage Group
n=14 Participants
sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage not directed at wound or patient
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Number of subjects >=18 years
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Sex/Gender, Customized
male gender
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: study participation - up to 6 weeksLinear assessment of wounds
Outcome measures
| Measure |
Pulsatile Lavage Group
n=14 Participants
pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed
|
Sham Lavage Group
n=14 Participants
sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage to not directed at wound or patient
|
|---|---|---|
|
Pressure Ulcer Geometry
Length in cm
|
3.5 cm
Interval 2.47 to 4.54
|
4.9 cm
Interval 3.53 to 6.32
|
|
Pressure Ulcer Geometry
Width in cm
|
2.9 cm
Interval 1.92 to 3.78
|
3.0 cm
Interval 1.3 to 4.65
|
|
Pressure Ulcer Geometry
Depth in cm
|
1.4 cm
Interval 0.59 to 2.2
|
2.5 cm
Interval 1.81 to 3.16
|
PRIMARY outcome
Timeframe: study participation - up to 6 weeksVolume of pressure ulcer was measured by the amount of fluid that could be used to fill the pressure ulcer which was covered by an occlusive dressing
Outcome measures
| Measure |
Pulsatile Lavage Group
n=14 Participants
pulsatile lavage therapy
Pulsatile Lavage: pulsatile lavage to wound bed
|
Sham Lavage Group
n=14 Participants
sham pulsatile lavage
sham pulsatile lavage: pulsatile lavage to not directed at wound or patient
|
|---|---|---|
|
Pressure Ulcer Volume Measurement
|
5.8 cm^3
Interval 2.79 to 8.79
|
12.4 cm^3
Interval 8.39 to 16.38
|
Adverse Events
Pulsatile Lavage Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Lavage Group
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