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Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers

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ClinicalTrials.gov Identifier: NCT01208220
Recruitment Status : Terminated (Low enrollment of qualified subjects)
First Posted : September 23, 2010
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
Healthpoint
Information provided by (Responsible Party):
Dr. Stanley McCallon, Louisiana State University Health Sciences Center Shreveport

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.


Condition or disease Intervention/treatment Phase
Pressure Ulcer Soft Tissue Necrosis Lower Limb Device: Negative Pressure Wound Therapy Biological: Collagenase Ointment Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Collagenase Santyl Ointment and Negative Pressure Wound Therapy(Npwt) for the Treatment of Chronic Pressure Ulcers.
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Negative pressure wound therapy
NPWT changed TIW
Device: Negative Pressure Wound Therapy
NPWT changed 3 times weekly
Other Name: NPWT

Experimental: NPWT plus Collagenase Ointment
Collagenase applied TIW with NPWT
Biological: Collagenase Ointment
Apply TIW




Primary Outcome Measures :
  1. Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) [ Time Frame: 2 weeks into study ]

Secondary Outcome Measures :
  1. Removal of Harmful Fluids in the Wound Tissue [ Time Frame: 2 weeks into study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208220


Locations
United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Healthpoint
Investigators
Principal Investigator: Stanley K McCallon, DPT LSUHSC professor

Responsible Party: Dr. Stanley McCallon, Assistant Professor - School of Physical Therapy, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT01208220     History of Changes
Other Study ID Numbers: Healthpoint-123-Collagenase
First Posted: September 23, 2010    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014
Last Verified: July 2014

Keywords provided by Dr. Stanley McCallon, Louisiana State University Health Sciences Center Shreveport:
Collagenase Santyl
Enzymatic debridement
maintenance debridement
VAC
NPWT

Additional relevant MeSH terms:
Ulcer
Necrosis
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases