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Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers

This study has been terminated.
(Low enrollment of qualified subjects)
Sponsor:
Collaborator:
Healthpoint
Information provided by (Responsible Party):
Dr. Stanley McCallon, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT01208220
First received: April 16, 2010
Last updated: July 16, 2014
Last verified: July 2014
  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
Pressure Ulcer
Soft Tissue Necrosis Lower Limb
Device: Negative Pressure Wound Therapy
Biological: Collagenase Ointment

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(Npwt) for the Treatment of Chronic Pressure Ulcers.

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone) [ Time Frame: 2 weeks into study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Removal of Harmful Fluids in the Wound Tissue [ Time Frame: 2 weeks into study ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: collagenase ointment

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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 16, 2010
Results First Received: September 24, 2013
Last Updated: July 16, 2014
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
Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on November 25, 2014