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A 2-week open-label, non-comparative, multicentre evaluation of the performance of a hydro-desloughing absorbent Technology Lipido-Colloid silver wound dressing.

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An open-label, non-comparative, multicentre evaluation of the performance of a hydro-desloughing absorbent Technology Lipido-Colloid silver wound dressing

Dr Katie Adolphus1, Professor Louise Toner1, Professor Jackie Stephen-Haynes1,2 Ms Michelle Deeth2,3

1: Wound Healing Practice Development Unit, Faculty of Health, Education & Life Sciences, Birmingham City University; 2: Worcestershire Health & Care Trust; 3: Urgo Medical

Introduction

Many acute and chronic wounds become contaminated with microorganisms, but do not show signs/symptoms of infection and wound healing is not impaired. However, when colonisation exceeds the threshold defining clinical infection (≥105 bacteria/g of tissue), signs/symptoms of infection are typically present and wound healing is impaired. A high proportion of acute and chronic wounds become infected, which often leads to significant morbidity and mortality.

Topical antimicrobial dressings, such as silver-containing dressings, are used to prevent or manage infection in wounds. However, few have shown to be fully effective. Moreover, to effectively treat local infection, dressings with combined antimicrobial and desloughing absorbent properties are required to remove all materials that may create a favourable environment for bacterial proliferation and biofilm formation.

Recently, an antimicrobial and absorbent dressing with a silver-containing Technology Lipido-Colloid (TLC-Ag) healing matrix has been developed: The UrgoClean Ag (Laboratories Urgo). The TLC-Ag dressing contains hydrophilic poly-absorbent fibres which effectively absorb exudate and drain sloughy residues. In vitro studies have demonstrated that UrgoClean Ag exhibits broad-spectrum antimicrobial and anti-biofilm activity. Moreover, previous multicentre RCTs have demonstrated a greater reduction in wound size, clinical signs of critical colonisation, and sloughy tissue using the UrgoClean Ag dressing in critically colonised chronic leg ulcers. However, there have been few evaluations of the TLC-Ag wound dressing in clinical practice.

Aim

This post CE-mark evaluation aimed to evaluate the efficacy, tolerance, and acceptability of the UrgoClean Ag, an hydro-desloughing absorbent TLC-Ag wound dressing in the management of acute and chronic exudative wounds at risk or with signs of local infection. 

Method

Design: 2-week open-label non-comparative multicentre case series.

Participants: n=13 hospitalised patients and outpatients with a range of wounds that are at risk or showing signs of infection.

Setting: Four investigations sites which were healthcare organisations in the UK.

Intervention/dressing product: The UrgoClean Ag.

An antimicrobial and absorbent dressing with TLC-Ag healing matrix.

Outcome measures: Signs and symptoms of local wounds infection, peri-wound skin condition, wound pain via 10-point Visual Analogue Scale (VAS) anchored by “no pain =1 to worst pain possible =10, level of exudate, application, conformability, condition of wound bed (% epithelialising, % slough, % granulation tissue, % necrosis), wound progression towards healing, estimated wound size (cm), ratings (excellent-poor) of: effectiveness in reducing infection, ability to clean wound bed, patient comfort, non-adherence to the wound, ease of removal.

Data collection procedures: A baseline evaluation assessment was carried out by the clinician following the participant’s agreement to take part. Subsequently, at every dressing change, an evaluation assessment occurred by a clinician to collect outcome data. A final evaluation assessment was conducted at the end of the evaluation to collect outcome data.

Results

Baseline demographics & wound assessment:

Demographics:

- Females: 8 [61.5%]); Males: 5 [38.5%]

- Mean age ± SD: 71.08 ± 15.52 years

- 5 (38.5%) patients were taking antibiotics at baseline

Wound assessment:

- Wound types: 3 (23.1%) pressure ulcers, 2 (15.4%) diabetic foot ulcers, 2 (15.4%) traumatic wounds, 2 (15.4%) mixed aetiology ulcers, 4 (30.8%) other wound types.

- Mean wound duration ± SD: 282 days ± 362.44

- Wound progression towards healing: 7 (53.8%) stagnant; 5 (38.5%) deteriorating; 1 (7.7%) improving.

- Level of excaudate: 7 (53.8%) moderate; 4 (30.8%) light; 2 (15.4%) heavy.

- Peri-wound skin condition: 8 (61.5%) inflamed; 7 (53.8%) fragile; 5 (38.5%) macerated; 2 (15.4%) non-blanching erythema. 

- Signs of local infection: 12 (92.3%) patients had signs of local infection most commonly: Peri-wound erythema (11 [84.6%]), increased exudate (10 [76.9%]), slough/necrosis in the wound bed (9 [69.2%]), localised pain (9 [69.2%]), localised heat (8 [61.5%) and malodour (7 [53.8%]).

- Wound bed condition: On average, the wounds consisted of 50% slough and 50% granulation tissue.

- Mean wound size (cm): 8.63 x 4.77 with a depth of 0.61

Pain assessment:

- Mean VAS wound pain ± SD: 4.17 ± 2.37

Changes at follow-up:

Average treatment times: 2 weeks

- Reduction in slough and increase in healthy granulation tissue: Mean percentage of slough reduced from 50% to 30%. Mean percentage of healthy granulation tissue increased from 50% to 60%.

- Improvement in wound progression towards healing: Most wounds showed improvement (70%) at follow-up. Of the wounds which were stagnant or deteriorating at baseline, 8/12 (67%) showed improvement at follow-up.

- Improvement in peri-wound skin condition: The number of wounds with non-blanching erythema, inflamed, and macerated skin reduced by 100%, 62.5%, and 40% respectively.

- Reduction in wound size: Mean wound size (cm) reduced to 5.47 x 2.38 with a depth of 0.2.

- Reduction in wound pain: Mean wound pain reduced from 4.17 to 3.54

- Reduction in the common signs and symptoms of local wound infection: Peri-wound erythema reduced in 55% of wounds, slough/necrosis in the wound reduced in 90% of wounds, malodour reduced in 78% of wounds, localised heat reduced in 60% of wounds, increased exudate reduced in 67% of wounds. 

Clinicians’ evaluation of the dressings:

Ease of application: 100% of clinicians rated as good to excellent

Conformability: 100% of clinicians rated as good to excellent

Effectiveness in reducing infection: 70% of clinicians rated as good to excellent

Ability to clean wound bed: 70% of clinicians rated as good to excellent

Patient comfort during wear: 77% of clinicians rated as good to excellent

Patient comfort during removal: 85% of clinicians rated as good to excellent

Non-adherence to the wound: 100% of clinicians rated as good to excellent

Ease of removal:100% of clinicians rated as good to excellent

How it compares to previous products: 62% of clinicians rated as more effective

Future use: 92% of clinicians would use UrgoClean Ag again if clinically indicated. 

Discussion and Conclusion

The hydro-desloughing absorbent TLC-Ag wound dressing:

- Progressed wounds towards healing

- Reduced slough

- Reduced signs and symptoms of infection

- Reduced wound pain

- Controlled exudate levels successfully

- Was rated highly by clinicians

The unique hydro-desloughing TLC-Ag wound dressing is a promising strategy to prevent or manage wound infection in a wide range of wounds. The dressing offers a novel and effective intervention to reduce the economic and health consequences of wound infection which is especially important in the context of growing resistance to antibiotics.

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