Malignant WoundTUMOSSNCT06581809
Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds (Tumoss)
A study testing Algosteril and Other Dressings: interface, hydrocellular, hydrofiber in people with Malignant Wound, run by Institut Curie at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malignant Wound
- What is being tested?
- Algosteril and Other Dressings: interface, hydrocellular, hydrofiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 12 sitesFrance
- Study dates
- 27 Mar 2025to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
EHPAD Laurent Antoine
Agde, 34300
Hôpital Saint-Loup
Agde, 34300
Centre François Baclesse
Caen, 14076
EHPAD Claude Goudet
Marseillan, 34340
CHU Saint Eloi
Montpellier, 34090
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
Hôpital Tenon
Paris, 75020
Institut Curie
Paris, 75248
CLCC - Institut Godinot
Reims, 51100
Hôpital Saint Clair
Sète, 34200
EHPAD Pergolines
Sète, 34207
EHPAD l'Estagnol
Vias, 34450
About this study
Official title: Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
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.
Read more
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.
Read the detailed description
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
- Malignant Wound
- Being tested
- Algosteril, Other Dressings: interface, hydrocellular, hydrofiber
- Keywords
- Malignant wound, Bleeding, Dressing
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgosterilOther
hemostatic dressing
Other Dressings: interface, hydrocellular, hydrofiberOther
Non-haemostatic dressing
| Study group | Role | What they receive |
|---|---|---|
| Algosteril | Active comparator | control arm (Algostéril® hemostatic dressing): dressing used on the day of the bleeding episode in hospital Receives: Other: Algosteril |
| Other dressings | Experimental | experimental arm (non-haemostatic dressing): dressing used on the day of the bleeding episode in hospital Receives: Other: Other Dressings: interface, hydrocellular, hydrofiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 after bleeding
Secondary outcomes (8)
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
Measured: Day 1 when the dressing is removed
Observe the frequency of bleeding over 6 months
Number of bleeding episodes over 6 months
Measured: 6 months
Describe the bleeding characteristics and its immediate consequences;
Percent of type of bleeding (sheet or jet / pulsatile bleeding)
Measured: 6 months
Describe local care at the time of a bleeding episode;
Type of the primary dressing used at the time of bleeding (percent)
Measured: 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))
Measured: 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)
Measured: 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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start27 Mar 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Why it stopped: failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, open-label/randomized, 2-arm parallel, superiority trial, national.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marguerite NICODEME, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581809
- Sponsor's protocol ID
- IC 2023-07
- Acronym
- TUMOSS
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
- ClinicalTrials.gov ID
- NCT06581809
- Acronym / sponsor ID
- TUMOSS / IC 2023-07
- Conditions
- Malignant Wound
- Keywords
- Malignant wound, Bleeding, Dressing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to recruit
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, open-label/randomized, 2-arm parallel, superiority trial, national.
| Arm | Type | Receives |
|---|---|---|
| Algosteril | Active comparator | Other: Algosterilcontrol arm (Algostéril® hemostatic dressing): dressing used on the day of the bleeding episode in hospital |
| Other dressings | Experimental | Other: Other Dressings: interface, hydrocellular, hydrofiberexperimental arm (non-haemostatic dressing): dressing used on the day of the bleeding episode in hospital |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algosterilhemostatic dressing | Other | Algosteril |
| Other Dressings: interface, hydrocellular, hydrofiberNon-haemostatic dressing | Other | Other dressings |
Primary outcome
Comparison of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode
Time frame: Day 1 after bleeding
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
8 secondary outcomes
Assess the pain at D1 when the dressing is removed
Time frame: Day 1 when the dressing is removed
Observe the frequency of bleeding over 6 months
Time frame: 6 months
Describe the bleeding characteristics and its immediate consequences;
Time frame: 6 months
Describe local care at the time of a bleeding episode;
Time frame: 6 months
Assess the stress of patients, family, and caregivers after a bleeding episode
Time frame: 6 months
Wound quality of life
Time frame: 5 months
Medical management of bleeding
Time frame: 6 months
Assess the bleeding episodes according to the dressing subgroups defined in the nonhemostatic group (Interface and absorbent drainage dressing)
Time frame: Day 1
Results and safety
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marguerite NICODEME study director
Institut Curie
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algosteril and Other Dressings: interface, hydrocellular, hydrofiber in people with Malignant Wound, run by Institut Curie at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of bleeding on primary dressing removal between a hemostatic dressing and a non-hemostatic dressing positioned following a first bleeding episode (time frame: Day 1 after bleeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.