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Percentage of patients achieving complete debridement in ≤42 days vs hydrogel dressings20

11 out of 13 patients treated with SANTYL Ointment experienced complete debridement within 42 days vs 4 out of 14 in the hydrogel group

Reduction of non-viable tissue was greater on a weekly basis in the SANTYL Ointment (SO) group (P<0.002)

Faster reductions were observed in overall wound size in the SO group (P<0.009)

85%

SANTYL Ointment20


P<0.003

29%

Hydrogel20

Study details

Study overview, endpoints, and design

Milne CT, et al. (2010)20
Objective

To compare SANTYL Ointment with a hydrogel* for initial debridement and promotion of ongoing, daily debridement in subjects with pressure ulcers

* SOLOSITE Gel

Primary endpoint Evaluating weekly wound photographs for necrotic tissue debridement using the PUSH Tool score Version 3.04 and Wound Bed Score
Limitations
  • Small number of enrolled patients
  • Results cannot be generalized to all hydrogels
  • Results cannot be generalized to wounds of other etiologies or outside the long-term care setting
  • Hydrogel was applied at 2mm thickness (consistent with investigator's standard clinical practice) instead of manufacturer's recommended 5mm thickness

Patient demographics

27 institutionalized patients with a pressure ulcer

SANTYL Ointment group; n=13

  • Age: 80.23 years (range 44–94)
  • Female: 29.6% | Male: 18.5%
  • Mean age of wound: 3.7 weeks (range 1–12)
  • Mean wound size: 12.29cm2
  • Mean prealbumin levels: 16.8

Hydrogel group; n=14

  • Age: 78.79 years (range 54–94)
  • Female: 25.9% | Male: 25.9%
  • Mean age of wound: 3.0 weeks (range 1–7)
  • Mean wound size: 7.90cm2
  • Mean prealbumin levels: 16.6

Mean wound size

The SANTYL Ointment group presented with wounds 55.5% larger than the hydrogel group.

Design

(single-blinded, randomized study)

  • Ulcers were treated for ≤42 days with daily dressing changes followed by an application of either hydrogel or SANTYL Ointment nickel thick to the entire wound bed
  • Investigators, who were blinded to randomization, evaluated weekly wound photographs for necrotic tissue debridement
Study results

Greater efficacy achieved with SANTYL Ointment vs hydrogel dressings20

  • 11 out of 13 patients treated with SANTYL Ointment experienced complete debridement within 42 days vs 4 out of 14 in the hydrogel group
  • Reduction of non-viable tissue was greater on a weekly basis in the SANTYL Ointment group (P<0.002)
  • Faster reductions were observed in overall wound size in the SANTYL Ointment group (P<0.009)
Alternate Text

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What's next?

TMean percent reduction in ulcer area with SANTYL Ointment vs silver-based products

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.