Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds (Tumoss)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter, open-label/randomized, 2-arm parallel, superiority trial, national.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Algosteril

control arm (Algostéril® hemostatic dressing): dressing used on the day of the bleeding episode in hospital

Group Type ACTIVE_COMPARATOR

Algosteril

Intervention Type OTHER

hemostatic dressing

Other dressings

experimental arm (non-haemostatic dressing): dressing used on the day of the bleeding episode in hospital

Group Type EXPERIMENTAL

Other Dressings: interface, hydrocellular, hydrofiber

Intervention Type OTHER

Non-haemostatic dressing

Interventions

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Algosteril

hemostatic dressing

Intervention Type OTHER

Other Dressings: interface, hydrocellular, hydrofiber

Non-haemostatic dressing

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No