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Low enrollment of qualified subjects
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| Name | Class |
|---|---|
| Healthpoint | INDUSTRY |
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Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds.
You are being asked to take part in this study because you have a wound on your body which has not responded to standard treatments.
The researchers will be studying whether the combination of two treatments will make wounds heal faster. For those in study, the investigators will treat them with a vacuum device on their wound. Also, some of the people in the study will receive a special ointment and researchers will use special tests to determine if the two treatments together are working better than just one treatment alone.
Evaluate the effectiveness of Collagenase Santyl ointment when used in conjunction with NPWT for the treatment of chronic pressure ulcers and determine whether the addition of Collagenase Santyl ointment has a positive effect on wound healing. Through volumetric changes and histological evaluation, we wish to test the hypothesis that the application of Collagenase Santyl ointment in conjunction with NPWT facilitates improved wound healing and mitigates some potentially harmful effects of NPWT alone (e.g. pain with dressing removal and tissue ingrowth
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative pressure wound therapy | Active Comparator | NPWT changed TIW |
|
| NPWT plus Collagenase Ointment | Experimental | Collagenase applied TIW with NPWT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | NPWT changed 3 times weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) | 2 weeks into study |
| Measure | Description | Time Frame |
|---|---|---|
| Removal of Harmful Fluids in the Wound Tissue | 2 weeks into study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley K McCallon, DPT | LSUHSC professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Health Sciences Center | Shreveport | Louisiana | 71103 | United States |
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Large acute care hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Santyl Ointment and NPWT | Enzymatic debriding ointment used in conjunction with negative pressure wound therapy Collagenase Santyl : Topical enzyme applied to wound tissue |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Santyl Ointment and NPWT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Removal of Harmful Fluids in the Wound Tissue | Posted | Number | percentage of cytotoxins removed | 2 weeks into study |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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No adverse events noted or reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stanley McCallon | LSUShreveport | 318-813-2996 | smccal@lsushc.edu |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| D017364 | Collagenases |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Collagenase Ointment | Biological | Apply TIW |
|
Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) | Posted | Number | Percentage of red granulation tissue | 2 weeks into study |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Santyl Ointment and NPWT | Enzymatic debriding ointment used in conjunction with negative pressure wound therapy Collagenase Santyl : Topical enzyme applied to wound tissue | 0 | 1 | 0 | 1 |
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| D008666 |
| Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |