Pressure Ulcer, Soft Tissue Necrosis Lower Limb
Conditions
Keywords
Collagenase Santyl, Enzymatic debridement, maintenance debridement, VAC, NPWT
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
Interventions
DEVICENegative Pressure Wound Therapy
NPWT changed 3 times weekly
BIOLOGICALCollagenase Ointment
Apply TIW
Sponsors
Healthpoint
Louisiana State University Health Sciences Center Shreveport
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) | 2 weeks into study |
Secondary
| Measure | Time frame |
|---|---|
| Removal of Harmful Fluids in the Wound Tissue | 2 weeks into study |
Countries
United States
Participant flow
Recruitment details
Large acute care hospital
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| Santyl Ointment and NPWT Enzymatic debriding ointment used in conjunction with negative pressure wound therapy
Collagenase Santyl : Topical enzyme applied to wound tissue | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Santyl Ointment and NPWT | Negative Pressure Wound Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 0 | 52 years STANDARD_DEVIATION 0 | 54 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
Time frame: 2 weeks into study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Negative Pressure Wound Therapy | Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) | 80 Percentage of red granulation tissue |
| Santyl Ointment and NPWT | Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) | 75 Percentage of red granulation tissue |
Secondary
Removal of Harmful Fluids in the Wound Tissue
Time frame: 2 weeks into study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Negative Pressure Wound Therapy | Removal of Harmful Fluids in the Wound Tissue | 0 percentage of cytotoxins removed |
| Santyl Ointment and NPWT | Removal of Harmful Fluids in the Wound Tissue | 0 percentage of cytotoxins removed |