Informations générales (source: ClinicalTrials.gov)
Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds (TUMOSS)
Interventional
N/A
Institut Curie (Voir sur ClinicalTrials)
mars 2025
décembre 2026
29 mars 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:06 | Contacter | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Estelle WYTSZITC | Contact (sur clinicalTrials) | |||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Virginie GANDRILLE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14076 - Caen - France | Julie TANQUEREL | Contact (sur clinicalTrials) | |||
| CHU Saint Eloi - 34090 - Montpellier - France | Marjorie LANDES | Contact (sur clinicalTrials) | |||
| CLCC - Institut Godinot - 51100 - Reims - France | Loubna DIOURI | Contact (sur clinicalTrials) | |||
| EHPAD Claude Goudet - 34340 - Marseillan - France | Virginie DELORME | Contact (sur clinicalTrials) | |||
| EHPAD Laurent Antoine - 34300 - Agde - France | Virginie DELORME | Contact (sur clinicalTrials) | |||
| EHPAD l'Estagnol - 34450 - Vias - France | Virginie DELORME | Contact (sur clinicalTrials) | |||
| EHPAD Pergolines - 34207 - Sète - France | Virginie DELORME | Contact (sur clinicalTrials) | |||
| Hôpital Saint Clair - 34200 - Sète - France | Virginie DELORME | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Loup - 34300 - Agde - France | Virginie DELORME | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.