Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers

Brief Summary

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

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2011

Detailed Clinical Trial 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 Used in this Clinical Trial

  • Device: Negative Pressure Wound Therapy
    • NPWT changed 3 times weekly
  • Biological: Collagenase Ointment
    • Apply TIW

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Negative pressure wound therapy
    • NPWT changed TIW
  • Experimental: NPWT plus Collagenase Ointment
    • Collagenase applied TIW with NPWT

Outcome Measures for this Clinical Trial

Primary Measures

  • Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)
    • Time Frame: 2 weeks into study
      Safety Issue?: No

Secondary Measures

  • Removal of Harmful Fluids in the Wound Tissue
    • Time Frame: 2 weeks into study
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Louisiana State University Health Sciences Center Shreveport
  • Collaborator
    • Healthpoint
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Stanley McCallon, Assistant Professor – School of Physical Therapy – Louisiana State University Health Sciences Center Shreveport
  • Overall Official(s)
    • Stanley K McCallon, DPT, Principal Investigator, LSUHSC professor


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