Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Pressure Ulcers Necrotic Tissue Inadequate Granulation Tissue |
Drug: Collagenase Santyl Device: NPWT - VAC |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effects of Collagenase Santyl Ointment and Negative Pressure Wound Therapy for the Treatment of Chronic Pressure Ulcers. |
- A significant reduction in the presence and quantity of chronic inflammatory cells in patients receiving Collagenase and Negative Pressure Wound Therapy (NPWT) (vs. NPWT alone) [ Time Frame: 2 weeks into study ] [ Designated as safety issue: No ]
- More robust granulation tissue formation (vs. treatment with NPWT alone) [ Time Frame: 2 weeks into study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Negative pressure wound therapy
NPWT alone for treatment of pressure ulcer
|
Device: NPWT - VAC
Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly
Other Names:
|
|
Experimental: Santyl Ointment and NPWT
Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
|
Drug: Collagenase Santyl
Topical enzyme applied to wound tissue
Other Names:
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| United States, Louisiana | |
| LSU Health Sciences Center | |
| Shreveport, Louisiana, United States, 71103 | |
| Principal Investigator: | Stanley K McCallon, DPT | LSUHSC professor |
More Information
No publications provided
| Responsible Party: | Stanley K. McCallon, PT, DPT Assistant Professor of Physical Therapy, Louisiana State University Health Sciences Center - Shreveport |
| ClinicalTrials.gov Identifier: | NCT01208220 History of Changes |
| Other Study ID Numbers: | Healthpoint-123-Collagenase |
| Study First Received: | April 16, 2010 |
| Last Updated: | April 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Louisiana State University Health Sciences Center Shreveport:
|
Collagenase Santyl Enzymatic debridement maintenance debridement VAC NPWT |
Additional relevant MeSH terms:
|
Pressure Ulcer Necrosis Ulcer |
Skin Ulcer Skin Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013