Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 12
- 主要终点
- Comparison of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode
研究概览
简要总结
The goal of this clinical trial is to compare of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode. This assessment will be made on adult patient with a malignant wound ≥ 10cm² who presents with a bleeding episode during a hospital consultation.
The primary endpoint is bleeding caused by the removal of a dressing applied during the first bleeding episode observed in the consultation.Effectiveness will be assessed by the resumption of bleeding during the following day's care, in order to respond to 2 care priorities: stopping the bleeding and avoiding its recurrence.The investigators propose a randomized study, with the choice between hemostatic (Algosteril®) or non-hemostatic (interface, hydrocellular, high-absorbency fiber dressing) being randomized and therefore not dependent on the wound or the care team.
In the proposed research, the investigators will evaluate pain on dressing removal, the stress that a bleeding episode can cause, and quality of life in relation to the malignant wound.
The investigators will observe the frequency of bleeding episodes over 6 months, the local care used and the medical management of these bleeding episodes.
In addition, the investigators will pay particular attention to the patient's entourage, as well as to the caregiver who will be carrying out the care, notably by measuring their stress levels during bleeding episodes.
详细描述
Malignant wounds are the result of the oncogenic process. They may be caused by the initial tumor ulcerating on the skin, or by a secondary localization of the cancer (cutaneous metastasis). They may be external, cavitary or superficial.
The most frequent symptoms are bleeding, odour, pain and exudate. The appearance of these wounds can be impressive for the patient, family and caregivers if they are not used to dealing with this type of wound.
As these wounds are chronic, they need to be managed both in hospital and at home.
A retrospective study carried out at the Institut Curie showed that in 80% of cases, bleeding occurred at the time of treatment.
This bleeding is due to the friable nature of the tissues, which are highly vascularized as a result of tumor angiogenesis. They can therefore bleed easily when the dressing is removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients 18 years and older;
- •Carriers of a malignant wound ≥ 10cm²;
- •Possibility of participating simultaneously in another research study without an exclusion period at the end of the study;
- •Patient having signed an informed consent
排除标准
- •Patient under 18 years of age;
- •Non-ulcerated nodule, tumor infiltration;
- •Patient in the terminal phase of their cancer;
- •Patients with a tumor wound that is a cutaneous melanoma;
- •Patient refusing to be managed by a private nurse or hospitalization at home (HAD);
- •Pregnant or breast-feeding women
- •Persons deprived of liberty or under guardianship (including curatorship);
- •Persons of legal age under court protection;
- •Inability to participate in the study for geographical, social, or psychological reasons.
研究组 & 干预措施
Algosteril
control arm (Algostéril® hemostatic dressing): dressing used on the day of the bleeding episode in hospital
干预措施: Algosteril (Other)
Other dressings
experimental arm (non-haemostatic dressing): dressing used on the day of the bleeding episode in hospital
干预措施: Other Dressings: interface, hydrocellular, hydrofiber (Other)
结局指标
主要结局
Comparison of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode
时间窗: Day 1 after bleeding
Bleeding rate on Day 1 of randomization, at the time of dressing change during a first bleeding episode. A bleed will be considered as a dressing removal for which the nurse had to: * use at least 2 packs of 5 compresses and * interrupt her care for \> 3 minutes to obtain hemostasis
次要结局
- Wound quality of life(5 months)
- Assess the pain at D1 when the dressing is removed(Day 1 when the dressing is removed)
- Observe the frequency of bleeding over 6 months(6 months)
- Describe the bleeding characteristics and its immediate consequences;(6 months)
- Describe local care at the time of a bleeding episode;(6 months)
- Assess the stress of patients, family, and caregivers after a bleeding episode(6 months)
- Medical management of bleeding(6 months)
- Assess the bleeding episodes according to the dressing subgroups defined in the nonhemostatic group (Interface and absorbent drainage dressing)(Day 1)