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An 8-week open-label, non-comparative, multicentre evaluation of the performance of a Technology Lipido-Colloid Nano-Oligosaccharide Factor wound dressing.

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An open-label, non-comparative, multicentre evaluation of the performance of a Technology Lipido-Colloid Nano-Oligosaccharide Factor 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

Delayed wound healing has adverse implications for the patient and clinician, in addition to causing a financial burden on the National Health Service. Numerous pharmacological and non-pharmacological treatments have been developed to improve the healing prognosis of chronic and long-standing acute wounds. However, few have shown to be fully successful in clinical practice.

Amongst the latest developments aimed at accelerating wound healing is a Technology Lipido-Colloid Nano-Oligosaccharide Factor (TLC-NOSF) wound dressing: the Urgo Start Border (Laboratories Urgo). The NOSF factor promotes wound closure through inhibition of matrix metalloproteinase (MMP) activity. This factor is incorporated within a TLC matrix and locally released in the wound. Exces­sive production of MMPs, coupled with reduced expression of the tissue inhib­itors of MMPs, is a key cause of slow or non-healing wounds. Excessive levels of MMPs can degrade extracellular matrix components, thereby impeding wound tissue regeneration and is responsible for a sustained inappropriate local inflammatory process. In vitro studies using a dermal equivalent model have demonstrated that a TLC-NOSF dressing was able to significantly reduce the activity of some MMPs. Furthermore, previous studies in over 10,000 participants, including multicentre randomised controlled trials (RCT), have shown superior wound healing using the TLC-NOSF wound dressing in the local management of venous leg ulcers, the most prevalent chronic wounds in western countries. However, there have been few evaluations of the TLC-NOSF wound dressing in clinical practice. 

Aim

This post CE-mark evaluation aimed to evaluate the efficacy, tolerance, and acceptability of the UrgoStart Border, a TLC-NOSF wound dressing in the local management of exuding chronic wounds and long-standing acute wounds. 

Method

Design: Open-label non-comparative multicentre case series.

Participants: n=6 hospitalised patients and outpatients with exuding chronic wounds and long-standing acute wounds.

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

Intervention/dressing product: The Urgo Start Border. A TLC-NOSF wound dressing.

Outcome measures: Peri-wound skin condition, dressing removal discomfort via 10-point Visual Analogue Scale (VAS) anchored by “no pain =1 to worst pain possible =10, level of exudate, ability to stay in place, condition of wound bed (% epithelialising, % slough, % granulation tissue, % necrosis), wound progression towards healing, estimated wound size (cm), clinician ratings (excellent-poor) of: Ease of application, ease of removal, ability to stay in place, patient comfort during wear and removal, conformability, condition of peri-wound skin, ability to handle exudate, ability to reduce wound size. 

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: 4 [66.7%]); Males: 2 [33.3%]

- Mean age ± SD: 62.80 ± 18.46 years

- 4 (66.7%) patients were taking analgesics at baseline

Wound assessment:

- Wound types: Long-standing acute wounds: 2 (33.3%) dehisced wounds, 1 (16.7%) surgical wound, 1 (16.7%) burn. Chronic wounds: 1 (16.7%) venous leg ulcer,1 (16.7%) pressure ulcer.

- Mean wound duration ± SD: 148.5 days ± 285.62

- Level of excaudate: 3 (50.0%) light/low; 2 (33.3%) moderate, 1 (16.7%) none.

- Peri-wound skin condition: 2 (33.3%) healthy, 1 (16.7%) inflamed; 1 (16.7%) dry & flaky; 1 (16.7%) macerated; 1 (16.7%) other. 

- Signs of local infection: No wounds had clinical signs of infection at baseline

- Wound bed condition: mean % slough: 30.0%, mean % granulation tissue: 88%, mean % epithelising tissue: 15%.

- Mean wound size (cm): 4.81 x 2.73 with a depth of 0.45

- 100% of clinicians found the dressing easy to apply at first dressing application at baseline. 

Changes at follow-up:

Average treatment times: 4.3 weeks as a primary dressing without any concurrent products to treat the wound.

- Increase in healthy granulation tissue and epithelising tissue, reduction in slough: Mean percentage of slough reduced to 20%. Mean percentage of healthy granulation tissue and epithelising tissue increased to 93.3% and 100% respectively.

- Improvement in wound progression towards healing: 83.3% of wounds healed or improved.

- Improvement in peri-wound skin condition: Peri-wound skin condition improved in 63% of wounds. The number of wounds with healthy peri-wound skin increased from 33.3% to 83.3%.

- Reduction in exudate: Wounds with no exudate increased to 33.3%

- Reduction in wound size: Mean wound size (cm) reduced to 2.67 x 1.45 with a depth of 0.2

- Pain-free dressing changes: Mean VAS dressing removal discomfort rating: 1.15 ± 0.94

Clinicians’ evaluation of the dressings:

Ability to stay in place: 83.3% of clinicians rated as very good to excellent

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

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

Patient comfort during wear:100% of clinicians rated as good to excellent

Patient comfort on removal: 100% of clinicians rated as good to excellent

Protection and improvement of peri-wound skin: 83.3% of clinicians rated as good to excellent

Ability to handle exudate: 83.3% of clinicians rated as good to excellent

Conformability: 83.3% of clinicians rated as good to excellent

Effectiveness in reducing wound size: 66.7% of clinicians rated as very good to excellent

Ability to accelerate wound healing: 66.7% of clinicians saw accelerated wound healing since using UrgoStart

Discussion and Conclusion

The Technology Lipido-Colloid Nano-Oligosaccharide Factor wound dressing offered the following benefits for patients and clinicians:

- Accelerated healing and faster recovery

- Easy to apply and stays in place when applied

- Easy to remove with pain-free dressing changes

- Protection and improvement of peri-wound skin

- High conformability to the wound bed

- High exudate management

- Improved patient quality of life: Very comfortable for patients

The TLC-NOSF wound dressing may represent a new opportunity to promote the healing process of chronic or long-standing acute wounds which can remain unhealed for months to years significantly impacting on the patient’s quality of life.

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