Trial Outcomes & Findings for Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers (NCT NCT01208220)
NCT ID: NCT01208220
Last Updated: 2014-07-17
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
2 weeks into study
Results posted on
2014-07-17
Participant Flow
Large acute care hospital
Participant milestones
| Measure |
Negative Pressure Wound Therapy
NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly
|
Santyl Ointment and NPWT
Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
Baseline characteristics by cohort
| Measure |
Negative Pressure Wound Therapy
n=1 Participants
NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly
|
Santyl Ointment and NPWT
n=1 Participants
Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue
|
Total
n=2 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
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 0 • n=99 Participants
|
57 years
STANDARD_DEVIATION 0 • n=107 Participants
|
54 years
STANDARD_DEVIATION 3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeks into studyOutcome measures
| Measure |
Negative Pressure Wound Therapy
n=1 Participants
NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly
|
Santyl Ointment and NPWT
n=1 Participants
Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue
|
|---|---|---|
|
Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
|
80 Percentage of red granulation tissue
|
75 Percentage of red granulation tissue
|
SECONDARY outcome
Timeframe: 2 weeks into studyOutcome measures
| Measure |
Negative Pressure Wound Therapy
n=1 Participants
NPWT alone for treatment of pressure ulcer
NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly
|
Santyl Ointment and NPWT
n=1 Participants
Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue
|
|---|---|---|
|
Removal of Harmful Fluids in the Wound Tissue
|
0 percentage of cytotoxins removed
|
0 percentage of cytotoxins removed
|
Adverse Events
Negative Pressure Wound Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Santyl Ointment and NPWT
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