Pilot Efficacy Study of MedCu Wound Dressings With Copper Oxide in Treating Pressure Sores and Post-op Wounds
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent reduction of wound size
研究概览
简要总结
Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.
详细描述
The study will be divided into 3 periods. Patients with pressure ulcers or post-operation wounds with wound areas of 2-30 cm2, who will accept participating in the study, pass all the accepted inclusion criteria, and sign the informed consent form, will be recruited. Then they will be treated with silver dressings for up to three weeks (first period). In case that the wounds will not show a reduction of at least 50% of the wound area during the first period, then the wounds will be treated with the copper oxide dressings for at least 3 weeks (second period). In case that there will be a clear improvement during the second period, the wounds may continue to be treated with the copper oxide dressings or with any other wound dressings according to the treating physician judgement and decision for an additional 3 weeks (third period) or earlier if the wound will be closed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wound size 2-30 cm
- •Non-infected wounds.
- •Having at least moderate blood perfusion into the affected limb as defined by palpable pulses (Dorsalis Pedis and/or Tibialis Posterior, unequivocally palpable). If no pulse is clearly present in vascular lab tests Ankle Brachial Index (ABI) should be 0.6< or if ABI > 1.3, then toe pressure of > 50 mmHg.
- •Having a body mass index (BMI) <40 Kg/m
- •Glycosylated haemoglobin (HbA1c) <12.0%.
- •Not undergoing any systemic or topical antibiotic treatment for the wound for a week before enrollment in the study.
- •The patient is able and eligible to sign written informed consent and participate in the study.
- •Be available for the entire study period, and ability and willingness to adhere to the requirements of the study.
- •In case of post-op wounds, at least three weeks post-op, wounds that do not show significant healing (reduction of wound size of less than 50% in 3 weeks)
排除标准
- •A clinically significant active or unstable cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease.
- •Psychiatric condition.
- •Active participation in an investigational trial within 30 days of the screening visit.
- •History of allergic reactions attributed to copper.
- •Patient with known allergy to at least thee drugs or other substances.
- •Any chronic or acute condition susceptible of interfering with the evaluation of the wound dressing effect.
- •Individuals using and need to continue use any type of topical agents in or on the wound.
- •Any form of substance abuse (including drug or alcohol abuse, excluding cannabis), psychiatric disorder or any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study.
- •Females who are pregnant, lactating, of child-bearing potential.
- •Fertile female subjects who are not willing to use an acceptable method of contraception during the study.
- •Subjects who are likely to be non-compliant or uncooperative during the study.
- •Wound related parameters:
- •The size of the wounds is reduced by more than 50% during the three weeks presiding the study.
- •Wounds in which local pressure cannot be avoided due to protruding bone, or any other complex rehabilitation procedure.
- •Wounds determined to be infected wounds.
- •Wounds that are considered to necessitate debridement in the operation room during the study.
- •Wounds that necessitate antibiotic treatment or needed antibiotic treatment one week prior to the trial.
- •Necrotic wounds.
- •Wound with tunnels of more than 3 cm.
- •Lab parameters:
- •Hemoglobin below 7.0 g/dl
- •White blood cells count > 14,000/ul
- •Albumin <2.5 g/dl
结局指标
主要结局
Percent reduction of wound size
时间窗: 9 weeks
The area and volume of the wounds will be measured every 7 days during the study period. The percent reduction as compared to the area and volume of the wounds at the commencement of the study and in relevance to the treatment (silver or copper oxide dressings) will be determined.
次要结局
- Number of infectious episodes(9 weeks)
- Percent of granulation tissue(9 weeks)