Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01208220
• Other study ID #: Healthpoint-123-Collagenase
• Status: Terminated
• Phase: N/A
• First received: April 16, 2010
• Last updated: July 16, 2014
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2014
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Soft Tissue Necrosis Lower Limb
• Ulcer

Intervention

Device:
• Negative Pressure Wound Therapy
NPWT changed 3 times weekly

Biological:
• Collagenase Ointment
Apply TIW

Locations

Country	Name	City	State
United States	LSU Health Sciences Center	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport	Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)		2 weeks into study	No
Secondary	Removal of Harmful Fluids in the Wound Tissue		2 weeks into study	No