Mean percent reduction in ulcer area from baseline at six weeks 62 % SANTYL Ointment + supportive care* + sharp debridement 1 (P<0.

Transcription

1 Evaluating two common adjuncts to sharp debridement in the treatment of diabetic foot ulcers Mean percent reduction in ulcer area from baseline at six weeks 62 % 40 % SANTYL Ointment + supportive care* + sharp debridement 1 (P<0.071) Silver products + supportive care + sharp debridement 1 SANTYL Ointment maintains the debridement process between episodic sharp debridements 2 Silver-based products are often used to treat wounds prophylactically for infection after sharp debridement is performed 1 *Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban [tm] 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 group was the clinician s choice.

2 Study Design Objective Primary endpoint Secondary endpoint Limitations Number of subjects 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 Evaluate mean percent change in ulcer area from baseline to the end of the treatment period (Week 6) in each treatment group Incidences of target ulcer infection in each treatment group during the treatment period were based on presence of clinical signs and symptoms of infection Evaluate mean percent change in ulcer area from baseline to the end of the follow-up period (Week 10) Study was not blinded 102 total patients in two equally-sized groups (with type 1 and 2 diabetes and non-ischemic diabetic foot ulcers) SANTYL Ointment group; n=51 Female 18% Male 82% Mean age: 56 Race: Alaskan native 2%, black 6%, white 92% Ethnicity: Hispanic/Latino 28%, not Hispanic 72% Mean wound area: 1.6cm 2 Silver group; n=51 Female 29% Male 71% Mean age: 58 Race: Alaskan native 0%, black 6%, white 93% Ethnicity: Hispanic/Latino 31%, not Hispanic 69% Mean wound area: 1.7cm 2 Design (randomized, multicenter, parallel group study) 10-week group study: Six weeks of treatment, four weeks of follow-up Two arms: SANTYL Ointment (QD) + supportive care* + periodic sharp debridement Product containing silver + supportive care + periodic sharp debridement All patients agreed to wear an appropriate offloading device. *Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban [tm] 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 group was the clinician s choice.

3 The role of debridement in bioburden management Chronic wounds are typically stuck in the inflammatory phase of healing and are at a higher risk of infection 2 When infection is present in a wound, necrotic tissue must be debrided 2,3 Effective debridement removes necrotic tissue, eliminating the food source for bacteria 2 Infection can be a significant barrier to healing 2 Necrotic tissue is like a grocery store for bacteria 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. 2

4 The TIME principles for wound bed preparation recommend debridement as a necessary step in bioburden management 4,5 T I M E Tissue is non-viable or deficient Infection, inflammation, and biofilm Moisture imbalance Epithelial edge advancement Debridement Bioburden management Exudate management Promote epithelialization

5 Study shows SANTYL Ointment + sharp achieved clinically meaningful results vs silver + sharp 1 The SANTYL Ointment group demonstrated a 62% mean reduction from baseline in ulcer area at Week 6, compared to 40% in the silver treatment group (P<0.071) 1 PRIMARY ENDPOINT Mean percent change in ulcer area from baseline at six weeks 0 10 P< P< % n=51 40% n=51 SANTYL Ointment + supportive care* + periodic sharp debridement Product containing silver + supportive care + periodic sharp debridement A secondary endpoint evaluated target ulcer infection rate based on clinical signs and symptoms of infection; all 102 study subjects were considered to be free of infection when enrolled 1 o During the six-week treatment period, fewer ulcer infections were observed in patients treated with SANTYL Ointment (n=5) than in patients treated with silver-based products (n=11); (P=0.208)¹ *Supportive care in the SANTYL Ointment group included ALLEVYN Foam Dressing, cast padding, and Coban [tm] 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 group was the clinician s choice.

6 DEBRIDEMENT AND BIOBURDEN MANAGEMENT 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. 6 SECONDARY ENDPOINT Incidences of target ulcer infection based on clinical signs and symptoms of infection during the six-week treatment period 102 study subjects considered free of infection at enrollment 5 SANTYL Ointment group 1 n=5 vs (P=0.208) 11 Silver products group 1 n=11 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) 1 References: 1. Data on file. CSR Smith & Nephew, Inc Enoch S, Harding K. Wound bed preparation: the science behind the removal of barriers to healing. Wounds. 2003;15: Frykberg RG, Banks J. Challenges in the treatment of chronic wounds. Adv Wound Care. 2015;4: Schultz GS, Sibbald RG, Falanga V, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003;11(Suppl 1):S1-S8. 5. Leaper DJ, Schultz G, Carville K, et al. Extending the TIME concept: what have we learned in the past 10 years? Int Wound J. 2012;9(Suppl 2): Jovanovic A, Ermis R, Mewaldt R, Shi L, Carson D. The influence of metal salts, surfactants, and wound care products on enzymatic activity of collagenase, the wound debriding enzyme. Wounds. 2012;24: Advanced Wound Management Smith & Nephew, Inc. Fort Worth, TX USA Customer Care Center T F Smith & Nephew, Inc. Trademark of Smith & Nephew. SACE UE