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Mean percent reduction in ulcer area of SANTYL Ointment vs wet-to-dry + sharp (2013)

The SANTYL Ointment (SO) group showed a statistically significant reduction in wound area from baseline at the end of treatment phase

The SO group required only 1.0 debridement (at baseline) over the course of the entire study

During the post-treatment follow-up period zero sharp debridements in the SO group were performed

45%
from baseline
at Week 4

SANTYL Ointment19 (P=0.016)


0%
from baseline
at Week 4

Control group: sharp debridement + wet-to-dry19
(P=ns*)

*ns=not significant

Study details

Study overview, endpoints, and design

Tallis A, et al. (2013)19
Objective Compare the clinical effectiveness of SANTYL Ointment with that of wet-to-dry debridement (saline-moistened gauze, SMG) plus periodic sharp debridement on diabetic foot ulcers.
Primary endpoint Evaluate percent decrease in wound area at four weeks and at 12 weeks.
Limitations The decision to perform sharp debridement was left to the subjective judgment of individual investigators.
Wound assessment scores No significant differences were found in mean wound assessment total scores between the wet-to-dry SMG group and the SO group.

Number of subjects

48 patients with DFUs

Design

(prospective, parallel group, open-label, multicenter, randomized)

12-week trial:

  • Four-week treatment phase
  • Eight-week post-treatment phase where they were monitored to complete wound closure

Two equally-sized groups:

  • SANTYL Ointment (SO group); n=24
  • SMG + sharp when necessary (SMG group); n=24
  • Ulcers were measured and surgically debrided at baseline
  • Patients in the SO group who received surgical debridement were removed from the study
  • All patients wore an offloading boot or other device to aid in healing
  • Patients in both treatment groups had approximately four follow-up visits
Study results

SANTYL Ointment provided significant improvement19

  • The SANTYL Ointment group showed a statistically significant reduction in wound area at the end of the treatment phase that continued for an additional eight weeks (P=0.016; P=0.012)
  • The SMG group required a mean of 6.9 sharp debridements over the course of the study while the SO group required 1.0 (the baseline debridement)
  • During the post-treatment follow-up period, a mean of 2.8 sharp debridements were performed in the SMG group compared with zero in the SO group

There was one instance of sharp debridement after the treatment phase in the SO group; this did not affect the mean

*ns=not significant

Alternate Text
What's next?

Retrospective analysis: efficacy vs medicinal honey

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.