Collagenase SANTYL Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.
Mean percent reduction in ulcer area from baseline at six weeks26
(P<0.071)
* Supportive care in the SANTYL Ointment group included ALLEVYN◊ Foam Dressing, cast padding, and Coban™ or equivalent bandages.
† All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.
‡ Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.
§ Supportive care in the control (silver) group was the clinician’s choice.
¶ SANTYL Ointment is not indicated for the treatment or prevention of infection.
Objective | The primary objective was to compare the mean percent change in ulcer area from baseline to the end of the six-week treatment period in subjects receiving a daily application of SANTYL Ointment versus a comparator product containing silver |
Primary endpoint | Evaluate mean percent change in ulcer area from baseline to the end of the treatment period (Week 6) in each treatment group |
Secondary endpoints |
|
Limitations | Small sample size Study was not blinded |
Number of subjects (with type 1 or 2 diabetes mellitus and an open neuropathic foot ulcer) |
102 total patients in two equally sized groups SANTYL Ointment group; n=51
Silver group; n=51
|
Design (randomized, multicenter, parallel group study) |
10-week group study: Six weeks of treatment, four weeks of follow-up Two arms:
All patients agreed to wear an appropriate offloading device. |
* Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban or equivalent bandages.
† All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.
‡ Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.
§ Supportive care in the control (silver) group was the clinician’s choice.
* Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban or equivalent bandages.
† All subjects underwent sharp debridement prior to the application of the assigned test article and as medically necessary at any of the scheduled study visits.
‡ Product containing silver was the investigator’s choice and was applied according to site procedures and the specific product’s Instructions for Use.
§ Supportive care in the control (silver) group was the clinician’s choice.
¶ SANTYL Ointment is not indicated for the treatment or prevention of infection.
When infection is present in a wound, necrotic tissue must be debrided13,27
Effective debridement removes necrotic tissue, eliminating the food source for bacteria13
Infection can be a significant barrier to healing13
“Research has demonstrated that the presence of necrotic tissue in the wound bed is associated with wound infection, and its removal works on several levels to reduce bacterial burden.”13
Ongoing, daily enzymatic debridement with SANTYL Ointment can be effectively used in conjunction with treatments that address infection, including certain silver dressings, wound cleansers, and antimicrobials.21
During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment than in patients treated with silver-based products (P=0.208).
All 102 study subjects considered free of infection at enrollment
n=5 out of 51
(P=0.208)
n=11 out of 51
*SANTYL Ointment is not indicated for the treatment or prevention of infection
Important Safety Information:Use of SANTYL Ointment should be terminated when debridement is complete and granulation tissue is well established.
One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound.