Clinical trial NCT01208220: 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
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Soft Tissue Necrosis Lower Limb
Keywords: Collagenase Santyl
Enzymatic debridement
maintenance debridement
VAC
NPWT
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
Collaborators: name: Healthpoint
First posted: 2010-09-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
timeFrame: 2 weeks into study
Secondary outcomes:
measure: Removal of Harmful Fluids in the Wound Tissue
timeFrame: 2 weeks into study
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
Study officials:
affiliation: LSUHSC professor
name: Stanley K McCallon, DPT
role: PRINCIPAL_INVESTIGATOR
References: