Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
NCT Number: NCT06581809
Acronym: TUMOSS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malignant Wound
Interventions: OTHER: Algosteril|OTHER: Other Dressings
Sponsor: Institut Curie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-30
Completion Date: 2026-12-30
Locations: EHPAD Laurent Antoine, Agde, 34300, France|Hôpital Saint-Loup, Agde, 34300, France|Centre François Baclesse, Caen, 14076, France|EHPAD Claude Goudet, Marseillan, 34340, France|CHU Saint Eloi, Montpellier, 34090, France|Groupe Hospitalier Diaconesses Croix Saint Simon, Paris, 75020, France|Hôpital Tenon, Paris, 75020, France|Institut Curie, Paris, 75248, France|CLCC - Institut Godinot, Reims, 51100, France|Hôpital Saint Clair, Sète, 34200, France|EHPAD Pergolines, Sète, 34207, France|EHPAD l'Estagnol, Vias, 34450, France

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.

Primary Outcome Measures: 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 Outcome Measures: Assess the pain at D1 when the dressing is removed, Visual Analog Pain Scale (scale from 0 to 10).A higher score indicates greater pain intensity, Day 1 when the dressing is removed|Observe the frequency of bleeding over 6 months, Number of bleeding episodes over 6 months, 6 months|Describe the bleeding characteristics and its immediate consequences;, Percent of type of bleeding (sheet or jet / pulsatile bleeding), 6 months|Describe local care at the time of a bleeding episode;, Type of the primary dressing used at the time of bleeding (percent), 6 months|Assess the stress of patients, family, and caregivers after a bleeding episode, Stress Visual Analogue Scale (scale from 0 (no stress) to 10 (stress maxi)), 6 months|Wound quality of life, Wound Quality of Life Scale (5 suggested answers per question: not at all, a little, moderately, quite a bit and a lot), 5 months|Medical management of bleeding, Description of medical management related to bleeding: treatment initiated or modified; hemoglobin control; Transfusion; hemostatic radiotherapy; surgical or radiological management (embolization); sedation for the refractory symptom of bleeding in end-of-life patients, 6 months|Assess the bleeding episodes according to the dressing subgroups defined in the nonhemostatic group (Interface and absorbent drainage dressing), Description of induced bleeding on Day 1 according to the non-hemostatic dressing subgroup, Day 1