Back to resultsEffectiveness Study of Santyl Ointment to Treat Pressure Ulcers
Primary Purpose
Pressure Ulcer, Soft Tissue Necrosis Lower Limb
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Collagenase Ointment
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer focused on measuring Collagenase Santyl, Enzymatic debridement, maintenance debridement, VAC, NPWT
Eligibility Criteria
Inclusion Criteria:
- 18 to 85 year-old competent adults in inpatient setting (no prisoners, mentally ill, or children)
- Pressure ulcers to pelvis/abdomen/trunk and or upper extremities which have been refractory to prior treatment interventions and contain less than or equal to 25% necrotic tissue in wound bed (as percentage of total surface area)
Exclusion Criteria:
- Lower extremity/foot wounds related to arterial insufficiency, incarcerated individuals, patients with untreated osteomyelitis, uncorrected coagulopathy, malignancy, sensitivity to collagenase, wounds with evidence of clinical infection (via swab culture or punch biopsy)
Sites / Locations
- LSU Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Negative pressure wound therapy
NPWT plus Collagenase Ointment
Arm Description
NPWT changed TIW
Collagenase applied TIW with NPWT
Outcomes
Primary Outcome Measures
Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
Secondary Outcome Measures
Removal of Harmful Fluids in the Wound Tissue
Full Information
NCT ID
NCT01208220
First Posted
April 16, 2010
Last Updated
July 16, 2014
Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Healthpoint
1. Study Identification
Unique Protocol Identification Number
NCT01208220
Brief Title
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
Official Title
The Effects of Collagenase Santyl Ointment and Negative Pressure Wound Therapy(Npwt) for the Treatment of Chronic Pressure Ulcers.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment of qualified subjects
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Healthpoint
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Soft Tissue Necrosis Lower Limb
Keywords
Collagenase Santyl, Enzymatic debridement, maintenance debridement, VAC, NPWT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative pressure wound therapy
Arm Type
Active Comparator
Arm Description
NPWT changed TIW
Arm Title
NPWT plus Collagenase Ointment
Arm Type
Experimental
Arm Description
Collagenase applied TIW with NPWT
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy
Other Intervention Name(s)
NPWT
Intervention Description
NPWT changed 3 times weekly
Intervention Type
Biological
Intervention Name(s)
Collagenase Ointment
Intervention Description
Apply TIW
Primary Outcome Measure Information:
Title
Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
Time Frame
2 weeks into study
Secondary Outcome Measure Information:
Title
Removal of Harmful Fluids in the Wound Tissue
Time Frame
2 weeks into study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 85 year-old competent adults in inpatient setting (no prisoners, mentally ill, or children)
Pressure ulcers to pelvis/abdomen/trunk and or upper extremities which have been refractory to prior treatment interventions and contain less than or equal to 25% necrotic tissue in wound bed (as percentage of total surface area)
Exclusion Criteria:
Lower extremity/foot wounds related to arterial insufficiency, incarcerated individuals, patients with untreated osteomyelitis, uncorrected coagulopathy, malignancy, sensitivity to collagenase, wounds with evidence of clinical infection (via swab culture or punch biopsy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley K McCallon, DPT
Organizational Affiliation
LSUHSC professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
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