Skin Reactions Related to Thoracic Implantable Chamber Dressings
ConditionSkin Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorInstitut Curie
About this trial
Prospective, multicenter cohort of 500 patients newly treated with systemic chemotherapy with CCI. The main objective of this study is to measure the incidence of skin reactions related to thoracic implantable chamber dressings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age
New chemotherapy patients (1st line of treatment only)
Thoracic PAC
Disqualifiers
PICC Line and femoral PAC;
Patients undergoing treatment with bi-specific antibodies (e.g. tebentafusp);
Disunion requiring treatment
Patients treated for hematological cancer;
Trial population
Patient with thoracic CCI treated with chemotherapy in a day hospital ward at the Institut Curie Paris or the Centre Hospitalier de Polynésie Française or the Uturoa Hospital (French Polynesia).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Thoracic catheter port / 1st line chemotherapy
Trial outcomes
Primary outcomes
1
Measuring the incidence of skin reactions associated with thoracic implantable chamber dressings
Appearance of itching and/or erythema (defined as diffuse or localized congestive redness of the skin) at the dressing site
Time frame
through study completion, an average of 18 monthsSecondary outcomes
1
Identify risk factors for skin reactions to dressings
correlation between the onset of skin reactions and the treatments administered
Time frame
through study completion, an average of 18 months2
Identify risk factors for skin reactions to dressings
Percentage of patients with skin reactions according to the type of dressing used
Time frame
through study completion, an average of 18 months3
Identify risk factors for skin reactions to dressings
Percentage of patients with skin reactions according to the immune status (polynuclear/monocytic);
Time frame
through study completion, an average of 18 months4
Identify risk factors for skin reactions to dressings
Percentage of patients with skin reactions according to the duration of application of dressing
Time frame
through study completion, an average of 18 monthsSponsors and contacts
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Source ClinicalTrials.gov