Comparing dressing types for bleeding in malignant wounds

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

This study tests whether special dressings that help stop bleeding work better than regular dressings for adults with large malignant wounds during dressing changes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Institut Curie (Academic / other)
• Locations: 12 sites (Agde and 11 other locations)
• Trial ID: NCT06581809 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of hemostatic versus non-hemostatic dressings in managing bleeding during dressing changes in patients with malignant wounds. Adult patients with wounds measuring 10cm² or larger who experience bleeding during a hospital consultation will be randomly assigned to receive either an alginate hemostatic dressing or a non-hemostatic dressing. The primary focus is to assess the amount of bleeding caused by dressing removal and to evaluate pain levels associated with the process. The study seeks to improve care strategies for managing chronic malignant wounds, which often present significant challenges for patients and caregivers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with malignant wounds measuring 10cm² or larger.

Not a fit: Patients with non-ulcerated tumors, terminal cancer, or those with specific exclusions such as cutaneous melanoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of bleeding in patients with malignant wounds, enhancing their quality of life.

How similar studies have performed: While this approach is based on existing knowledge of wound management, the specific comparison of hemostatic versus non-hemostatic dressings in this context is novel.

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.

Where this trial is running

Agde and 11 other locations

• EHPAD Laurent Antoine — Agde, France (Not_yet_recruiting)
• Hôpital Saint-Loup — Agde, France (Not_yet_recruiting)
• Centre François Baclesse — Caen, France (Not_yet_recruiting)
• EHPAD Claude Goudet — Marseillan, France (Not_yet_recruiting)
• CHU Saint Eloi — Montpellier, France (Recruiting)
• Groupe Hospitalier Diaconesses Croix Saint Simon — Paris, France (Not_yet_recruiting)
• Hôpital Tenon — Paris, France (Not_yet_recruiting)
• Institut Curie — Paris, France (Recruiting)
• CLCC - Institut Godinot — Reims, France (Recruiting)
• Hôpital Saint Clair — Sète, France (Not_yet_recruiting)
• EHPAD Pergolines — Sète, France (Not_yet_recruiting)
• EHPAD l'Estagnol — Vias, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Marguerite NICODEME

Conditions Malignant Wound; Malignant wound; Bleeding; Dressing