The Use of a Decellularised Porcine Placental Extracellular Matrix in Hard-to-heal Wounds: A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Percent Area Reduction
研究概览
简要总结
The use of a decellularised porcine placental extracellular matrix in hard-to-heal wounds: A retrospective study of the real-world performance of InnovaMatrix® AC at a single centre.
详细描述
Hard-to-heal wounds are defined as wounds that do not transition through the normal phases of healing in a timely manner.1 With a global prevalence of ~1.9 per 1000, it is predicted that the incidence will increase with the ageing population.2-5 Furthermore, hard-to-heal wounds are associated with a significant reduction in health-related quality of life and place a great burden on healthcare systems.4,6-9 In the UK, the annual National Health Service cost of wound management in 2017/2018 was £8.3 billion; £2.7 billion and £5.6 billion were associated with managing healed and unhealed wounds, respectively.5 Moreover, wound care accounts for 2-4% of healthcare expenditure in Europe and costs $28 billion USD per year in the US.7-11
Specifically, the cost of care for diabetic patients with a diabetic foot ulcer (DFU) vs. those without a DFU is 5.4 times higher in the year after first diagnosis while costs for treatment of highest grade ulcers are 8 times higher than low-grade ulcers.12 Use of advanced therapies, while sometimes costly, have been shown to reduce long-term costs, including reduced foot complications and lower amputation rates.12 In 1998, Holzer et al conducted a retrospective analysis of the costs for lower extremity ulcers in patients with diabetes and concluded that, given the high costs associated with treating these ulcers, the development of better treatment strategies is warranted.13 One such advanced therapy in the treatment of chronic wounds is the use of Cellular, Acellular and Matrix-like products (CAMPs). These materials have been used successfully for many years in the treatment of hard-to-heal wounds, as well as other applications including soft tissue repair, tendon/ligament repair, plastic/reconstructive surgeries, and urological surgery.
In wound care, CAMPs were developed as an alternative to skin grafts in the management of hard-to-heal wounds. They are derived from either natural or synthetic sources, which provide an artificial extracellular matrix (ECM) that allows for infiltration of host cells. Natural sources include human cadaver skin processed to remove the cellular components and retain the structural proteins of the dermis, and collagen obtained from bovine and porcine sources. Synthetic sources include various degradable polymers.
Numerous studies have explored the safety and performance of CAMPs. Kavros, et.al. performed a prospective, multicentre study that included 71 patients to evaluate the usage of PriMatrix® for diabetic foot ulcers.14 Sixteen patients failed to meet inclusion and exclusion criteria so only 55 patients were enrolled in the intent-to-treat (ITT) population. A total of 46 patients completed the 12-week study period. Thirty-five of the 46 patients (76%) were healed at 12 weeks and the patients that were not completely healed had a reduction in wound area of 71.4% at 12 weeks. One of the ITT patients discontinued from the study had a complication related to the wound in the study. The authors concluded," the results from this multicentre perspective study demonstrate that PriMatrix® coupled with debridement, moist wound therapy, and pressure offloading is a successful strategy to heal chronic DFUs."14
Frykberg, et.al. executed a multi-centre randomised clinical trial to compare the efficacy of MatriStem MicroMatrix and MatriStem Wound Matrix to Dermagraft in the management of non-healing diabetic foot ulcers.15 Fifty-six patients were randomised in a 1:1 ratio between the two treatment groups. No statistical difference in demographic make-up was observed between the treatment groups. Wound measurements were assessed using a digital wound measurement system. All subjects completed a Patient-Reported Outcome Measures (PROMs) questionnaire at multiple time points during the study. The results of the interim analysis did not demonstrate a statistical difference in wound outcomes between the two study products but there was a significant difference in treatment costs favouring MatriStem.15
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18 years or older at the time the data were reported.
- •Subjects with hard-to-heal wound(s), defined as those that have failed to show improvement (which is defined as ≥50% reduction in wound area) over 4-weeks of standard wound care.
- •Initial Wound area that is >0.5 cm2 and <10 cm2
- •InnovaMatrix® AC applied to target wound(s) for a minimum of two consecutive weekly visits inside a 4-week period.
- •Subjects were compliant with wound protection strategies through treatment period (offloading, compression, etc).
- •The target wound(s) is not undergoing active management at the time of data entry.
排除标准
- •Wound area showed ≥50% reduction in 4-weeks preceding initial InnovaMatrix® AC application.
- •Cases where InnovaMatrix® AC was not applied at a minimum of two consecutive weekly visits inside a 4-week period.
- •Subjects who were non-compliant with additional wound protection strategies (offloading, compression, etc)
- •Subjects with severe comorbidities that significantly impact healing ability, or ability for subject to be compliant with wound protection strategies, such as: peripheral vascular disease (ABI <0.4, >1.3)1, severely uncontrolled diabetes (Hgb A1C >9.0%), neurodegenerative disorders, Charcot foot, high dose corticosteroid or other immunosuppressant, etc
- •Wound area <0.5 cm2 or >10 cm2
- •The target wound is still under active treatment.
结局指标
主要结局
Percent Area Reduction
时间窗: 4 months
Percent area reduction of target wound area at 4 weeks compared to baseline will be listed and tabulated over all eligible subjects, as calculated by wound length multiplied by wound width.
次要结局
- Time to Complete Wound Closure(4 months)
- Percent Granulation Tissue(5 months)
- Change in percent epithelialisation tissue(4 months)