Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581809
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Evaluation of Care Strategies on Dressing Change-induced Bleeding in Patients With Bleeding Malignant Wounds
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TUMOSS
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 consultationEffectiveness will be assessed by the resumption of bleeding during the following days care in order to respond to 2 care priorities stopping the bleeding and avoiding its recurrenceThe 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 patients entourage as well as to the caregiver who will be carrying out the care notably by measuring their stress levels during bleeding episodes
The primary endpoint is bleeding caused by the removal of a dressing applied during the first bleeding episode observed in the consultationEffectiveness will be assessed by the resumption of bleeding during the following days care in order to respond to 2 care priorities stopping the bleeding and avoiding its recurrenceThe 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None