UrgoStart Plus Non-Border

Description

UrgoStart Plus Border is a highly absorbent adhesive dressing with poyabsorbent fibres and a TLC-NOSF* matrix .

*TLC-NOSF: Technology Lipido Colliod- Nano Oligosacchairde factor (KSOS: Potassium ocatasulfate sucrose salt)

Features

• TLC-NOSF Healing Matrix
• Poly-absorbant fibers
• Waterproof and breathable silione border
• Super-absorbent layers

Benefits

1. Simple:
   • Dressing can be used in every wound healing phase* including sloughy, granulating and epithelising wounds.exclude dry necrosis
   • Highly conformable and easy to reposition
   • Ready to use
   • Shower-proof and great for self care
   • Absorbs and retains exudate while allowing the wound to breathe to reduce the chances of wound becoming macerated.
   • Waterpoof backing not permeable to bacteria from outside environment.
   • Keeps moist coating integrity and good tensile strength to help with painfree and one-piece removal during dressing changes.
2. Effective:
   • Continously cleans, desloughs and absorbs exudate to keep wound clean after debridement and in between dressing changes.
   • Effectively heals by reducing excess MMPs present in wound.
   • Create a moist environment and stimulates fibroblasts proliferation to promote faster healing.
3. Reliable:
   • Efficacy proven by a robust pyramid of evidence which includes systematic reviews, RCT, observational studies and local case reports.
   • Recommended by international guidelines including IWGDF (International Working Group for the Diabetic Foot) and NICE (National Institute for Health and Care Excellence in the UK).

Indications

UrgoStart Plus Border is indicated for covering and treating the following skin wounds:

• leg ulcers (LU), diabetic foot ulcers (DFU), pressure ulcers (PU),
• other long-lasting or recurrent wounds or wounds at risk of long lasting.

UrgoStart Plus Border is intended to be used for all healing phases: it is suitable for application to wounds with fibrin and for application to wounds covered with granulation tissue.

Instructions

Link to application video here: https://youtu.be/DEee1x6O77A

1. Wound preparation:

• Clean the wound using the conventional care protocol, then rinse with normal saline.
• If an antiseptic has previously been used, rinse the wound carefully with normal saline before applying UrgoStart Plus Border.
• Carefully dry the skin around the wound.
• The use of UrgoStart Plus Border does not dispense with the need for mechanical debridement when required.

2. Dressing application:

• Carefully remove the protective tabs.
• Apply the micro-adherent central pad of UrgoStart Plus Border over the wound (the adhesive silicone edges must be at least 1 cm from the wound). Smooth the dressing.
• Apply a compression bandage over the dressing where prescribed.

Application of the Sacrum format:

• Position the dressing with the tip pointing downwards towards the bottom of the sacral region.

3. Dressing removal:

• Pressing on healthy skin, lift a corner of the dressing and remove it carefully.

4. Dressing changes:

• Remove the entire dressing when it is saturated and clean the wound if required. It is recommended that the UrgoStart Plus Border dressing be changed every 1 to 2 days during the wound desloughing phase, then as often as required by the volume of exudate and the clinical progress of the wound. It can be left in place for up to 7 days.
• Discard any unused parts of the dressing.

 

Clinical Evidence

1. EXPLORER: international multicentre double-blind Randomized Controlled Trial (RCT) on 240 patients (neuro-ischaemic DFU)1

• Complete wound closure rate at Week 20: TLC-NOSF dressing significantly increased the rate of complete closure vs neutral dressing with the same standard of care (48% vs 30%, p=0.002). 60% more wounds healed with TLC-NOSF dressing vs. neutral dressing.
• Time to reach complete wound closure (days): TLC-NOSF dressing allowed patients to reach complete closure 60 days sooner vs neutral dressing with the same standard of care (p = 0.029).
• Median Relative Wound Area Reduction (RWAR) at the end of follow-up compared with baseline: 98%; IQR: [58%; 100%].
• EXPLORER Cohort Analysis: The sooner the treatment is initiated, the better the outcomes for the patients2.

2. REALITY: pooled analysis from several observational studies on 10,220 patients (LU, DFU, PU)8
• Proportion of closed wounds was 30.8% at the end of follow-up ranging from 8 to 20 weeks (95% confidence interval: [29.9%; 31.7%]).
• Mean estimate time from baseline to wound closure was 111.3 days (95% confidence interval: [105.5; 117.2].
• Results consistent with those of Randomized Controlled Trials (RCTs) that showed that treatment with TLC-NOSF dressings promotes wound healing of LUs, DFUs, and PUs.

3. NEREIDES: multicentre open-label uncontrolled study in 41 patients (37 patients with LU, 3 patients with PU and 1 patient with another long-lasting ulcer)9
Results specific to UrgoStart Plus Pad:
• Relative wound reduction was 60.37% including 15.80% of wounds healed after 12 weeks of treatment. Median healing time was 57.5 days.
• 68.8% of wounds presented an RWAR > 40% at the end of week 12.
• Relative sloughy tissue reduction: percentage of sloughy tissue covering the surface of the wound at baseline and at the end of follow-up were 77.5% and 10% respectively.
• Percentage of debrided wounds was 69.4% after 12 weeks of treatment and mean time to obtain a debrided wound was 31.5 ± 19.5 days (median: 28 days).
• For the leg ulcers ≤ 6 months (n=16), median RWAR at week 12 was 85%.
• For the leg ulcers > 6 months (n=18), median RWAR was 43%.

4. CASSIOPEE: multicentre open-label uncontrolled study in 51 patients (LU)9
Results specific to UrgoStart Plus Pad:
• Relative wound area reduction was 81.17% after 12 weeks of treatment.
• Percentage of healed wounds was 19.60% for a median time to healing of 56.5 days.
• 79.5% of wounds presented an RWAR ≥ 40% at the end week 12.
• Wound outcome was judged by the investigator to be ‘healed/improved’ in 86% of cases.
• For the leg ulcers ≤ 6 months (n=23), median RWAR at week 12 was 81%.
• For the leg ulcers > 6 months (n=28), median RWAR was 82%.
• Relative reduction in sloughy tissue reached a plateau (-70.83%) after 8 weeks of treatment (value remained at the end of follow-up).
• Evaluation of the patient’s quality of life showed a slight improvement at the end of the study follow-up (66.3 vs 70.2 (mean)).

5. AWB URGOSTART PLUS 2017/2018: German Observational study on 1,140 patients whose 513 treated with UrgoStart Plus Border and 627 treated with UrgoStart Plus Pad (LU, DFU, PU, other long-lasting wounds)3,4
Results (full cohort):
• Mean treatment duration: 54.8 days.
• 93.3% of wounds improved (decrease of wound size) at the end of follow-up (12 weeks) compared with baseline; 48.6% of wounds healed and 86.9% of the wounds that did not heal improved.
• Median RWAR was 98.6% at the end of follow-up compared with baseline; IQR: [60.5%; 100.0%].
• Sloughy tissue mean proportion decreased from 45.2% at baseline to 14.7% at the end of follow-up.
• Local tolerance was very good or good for 98.7% of the wounds.
• Dressings were associated with no pain or short and merely detectable pain in 96.9% of the patients.
• Dressings were very well or well accepted by 98.1% of patients.

6.AWB URGOSTART PLUS 2019/2020: German Observational study on 961 patients whose 279 treated with UrgoStart Plus Border, 265 treated with UrgoStart Plus Pad, 233 treated with UrgoStart Plus Non Border and 184 patients with interchangeability (LU, DFU, PU, other long-lasting wounds)5,6
Results specific to UrgoStart Plus Pad:
• Mean treatment duration: 63.4 days.
• Proportion of healed wounds at the end of follow-up (12 weeks) was 43.0%.
• 79.8% of the wounds that did not heal greatly or slightly improved (50.3% greatly improved and 29.5% slightly improved).
• Median RWAR at the end of follow-up compared with baseline: 95.9%; IQR: [55.6%; 100.0%].
• Wounds needing debridement decreased from 61.9% at baseline to 15.5% at the end of the follow-up and the proportion of wounds in the epithelialising phase increased from 9.8% at baseline to 38.5% at the end of follow-up.
• UrgoStart Plus Pad was well or very well tolerated in 97.7% of the patients (6 missing data, 2.3%).
• UrgoStart Plus Pad was well or very well accepted in 92.1% of the patients at the end of follow-up.
For the full cohort, the health-related quality of life (HRQoL) global score and subscale scores (ie Body/physical, Psyche/psychological, Daily life) all improved significantly from baseline to the end of follow-up (questionnaires completed by 337 out of 961 patients, 35.1%).

REFERENCES
1. Edmonds M, Lázaro-Martínez JL, Alfayate-García JM, Martini J, Petit JM, Rayman G, Lobmann R, Uccioli L, Sauvadet A, Bohbot S, Kerihuel JC, Piaggesi A. Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018 Mar;6(3):186-196. Study on Urgostart Contact.
2. Lazaro et al. Optimal wound closure of diabetic foot ulcers with early initiation of TLC-NOSF treatment: post-hoc analysis of Explorer. JWC VOL 28, No 6, June 2019. Study on Urgostart Contact.
3. German Observational study AWB UrgoStart Plus Pad and UrgoStart Plus Pad 2017/2018. Internal report – Laboratoires Urgo. 2019.
4. Dissemond J, Lützkendorf S, Dietlein M, Neßeler I, Becker E, Möller U, Thomassin L, Bohbot S, Münter KC. Clinical evaluation of polyabsorbent TLC-NOSF dressings on chronic wounds: a prospective, observational, multicentre study of 1140 patients. J Wound Care. 2020 Jun 2;29(6):350-361. doi: 10.12968/jowc.2020.29.6.350. PMID: 32530781.
5. German observational study AWB UrgoStart Plus Pad, UrgoStart Plus and UrgoStart Plus Pad 2019/2020. Internal report – Laboratoires Urgo. 2021.
6. Augustin M, Keuthage W, Lobmann R, Lützkendorf S, Groth H, Möller U, Thomassin L, Bohbot S, Dissemond J, Blome C. Clinical evaluation of UrgoStart Plus dressings in real-life conditions: results of a prospective multicentre study on 961 patients. J Wound Care. 2021 Dec 2; 30(12):966-978. doi: 10.12968/jowc.2021.30.12.966. PMID: 34881999.
7. In vitro studies Laboratoires Urgo. Data on file.
8. Münter KC, Meaume S, Augustin M, Senet P, Kérihuel JC. The reality of routine practice: a pooled data analysis on chronic wounds treated with TLC-NOSF wound dressings. J Wound Care. 2017 Feb;26(Sup2): S4-S15. doi: 10.12968/jowc.2017.26.Sup2.S4. Erratum in: J Wound Care. 2017 Mar 2;26(3):153. PMID: 28182533. Studies on Urgostart Contact and Urgostart NA/Urgocell Start.
9. Sigal M-L, Addala A, Maillard, H, Chahim M, Sala F, Blaise S, Dalac S, Meaume S, Bohbot S, Tumba C, Tacca O. Evaluation of TLC-NOSF dressing with poly-absorbent fibres in exuding leg ulcers: two multicentric, single arm, prospective, open-label clinical trials. J Wound Care. 2019 Mar 3;28(3):164-175. doi: 10.12968/jowc.2019.28.3.164. Studies on Urgostart Plus Pad.