Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Effects of Collagenase Santyl Ointment and Negative Pressure Wound Therapy(Npwt) for the Treatment of Chronic Pressure Ulcers.

Conditions
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Pressure Ulcer, Soft Tissue Necrosis Lower Limb

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy
* Biological: Collagenase Ointment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Negative pressure wound therapy<br>NPWT changed TIW | Device: Negative Pressure Wound Therapy<br>* NPWT changed 3 times weekly<br>* Other names: NPWT;|
| Experimental: NPWT plus Collagenase Ointment<br>Collagenase applied TIW with NPWT | Biological: Collagenase Ointment<br>* Apply TIW<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) |  | 2 weeks into study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of Harmful Fluids in the Wound Tissue |  | 2 weeks into study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collagenase Santyl, Enzymatic debridement, maintenance debridement, VAC, NPWT