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

NCT06581809 | Terminated

• 1 other identifier: IC 2023-07
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 12

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.

Conditions

Malignant Wound

Keywords

Malignant wound; Bleeding; Dressing

Outcome Measures

Primary Outcomes (1)

• Comparison of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode

  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

  Day 1 after bleeding

Secondary Outcomes (8)

• 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

Study Arms (2)

Algosteril

ACTIVE COMPARATOR

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

Other: Algosteril

Other dressings

EXPERIMENTAL

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

Other: Other Dressings: interface, hydrocellular, hydrofiber

Interventions

Algosteril OTHER

hemostatic dressing

Algosteril

Other Dressings: interface, hydrocellular, hydrofiber OTHER

Non-haemostatic dressing

Other dressings

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older;
• Carriers of a malignant wound ≥ 10cm²;
• Patient having signed an informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (12)

EHPAD Laurent Antoine

Agde, 34300, France

Location

Hôpital Saint-Loup

Agde, 34300, France

Location

Centre François Baclesse

Caen, 14076, France

Location

EHPAD Claude Goudet

Marseillan, 34340, France

Location

CHU Saint Eloi

Montpellier, 34090, France

Location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Institut Curie

Paris, 75248, France

Location

CLCC - Institut Godinot

Reims, 51100, France

Location

Hôpital Saint Clair

Sète, 34200, France

Location

EHPAD Pergolines

Sète, 34207, France

Location

EHPAD l'Estagnol

Vias, 34450, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marguerite NICODEME

  Institut Curie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: September 3, 2024
• Study Start: March 27, 2025
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: April 22, 2026

Record last verified: 2025-09

Locations

FR (12)