Clinical trial NCT06581809: Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
Official title: Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Wound
Keywords: Malignant wound
Bleeding
Dressing
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, open-label/randomized, 2-arm parallel, superiority trial, national.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

The application of an alginate dressing, the only hemostatic dressing reimbursed in towns and cities (in France), seems to increase bleeding on dressing removal, compared with other, non-hemostatic products whose removal is less traumatic (interface, hydrocellular and hydrofiber).

The presence of minor bleeding is not negligible, as it appears to significantly increase the risk of more severe bleeding later on.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Comparison of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode
timeFrame: Day 1 after bleeding
Secondary outcomes:
measure: Assess the pain at D1 when the dressing is removed
timeFrame: Day 1 when the dressing is removed
measure: Observe the frequency of bleeding over 6 months
timeFrame: 6 months
measure: Describe the bleeding characteristics and its immediate consequences;
timeFrame: 6 months
measure: Describe local care at the time of a bleeding episode;
timeFrame: 6 months
measure: Assess the stress of patients, family, and caregivers after a bleeding episode
timeFrame: 6 months
measure: Wound quality of life
timeFrame: 5 months
measure: Medical management of bleeding
timeFrame: 6 months
measure: Assess the bleeding episodes according to the dressing subgroups defined in the nonhemostatic group (Interface and absorbent drainage dressing)
timeFrame: Day 1
Other outcomes:
Locations:
city: Agde
country: France
facility: EHPAD Laurent Antoine
city: Agde
country: France
facility: Hôpital Saint-Loup
city: Caen
country: France
facility: Centre François Baclesse
city: Marseillan
country: France
facility: EHPAD Claude Goudet
city: Montpellier
country: France
facility: CHU Saint Eloi
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: CLCC - Institut Godinot
city: Sète
country: France
facility: Hôpital Saint Clair
city: Sète
country: France
facility: EHPAD Pergolines
city: Vias
country: France
facility: EHPAD l'Estagnol
Study officials:
affiliation: Institut Curie
name: Marguerite NICODEME
role: STUDY_DIRECTOR
References: