Skin reactions from chest implantable port dressings
Skin Reactions Related to Thoracic Implantable Chamber Dressings
This study will see how often dressings on chest implantable ports cause skin reactions in adults starting first-line chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT07158879 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational cohort enrolling 500 adults starting first-line systemic chemotherapy who receive a thoracic implantable catheter chamber (ICC/PAC). Investigators will follow patients at participating centers to record skin reactions at the dressing site, such as persistent redness, itching, or dermabrasion, and measure the incidence of these events. The protocol excludes PICC or femoral lines, hematologic cancers, and patients receiving certain bi-specific antibody treatments. No experimental treatments are given; the study collects real-world data on current dressing practices across sites including Paris and French Polynesia.
Who should consider this trial
Good fit: Adults (18+) starting first-line systemic chemotherapy who will receive a thoracic implantable port (PAC/ICC) and can attend one of the participating centers are ideal candidates.
Not a fit: Patients with PICC lines or femoral ports, those treated for hematologic cancers, patients on excluded bi-specific antibody therapies, or those under legal guardianship are not expected to benefit from this study.
Why it matters
Potential benefit: If successful, the results could guide dressing choices and care practices to reduce the frequency and severity of skin reactions for patients with chest ports.
How similar studies have performed: Previous work has mainly focused on infectious complications and only small observational surveys have suggested high rates of dressing-related skin reactions, so large multicenter data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age * New chemotherapy patients (1st line of treatment only) * Thoracic PAC Exclusion Criteria: * PICC Line and femoral PAC; * Patients undergoing treatment with bi-specific antibodies (e.g. tebentafusp); * Disunion requiring treatment * Patients treated for hematological cancer; * Persons deprived of their liberty or under guardianship (including curatorship); * Adults under court protection; * Inability to participate in the study for geographical, social or psychological reasons. * No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.). * Opposition to data use
Where this trial is running
Paris and 2 other locations
- Institut Curie — Paris, France (Recruiting)
- Centre Hospitalier de Polynésie Française CHPF — Pirae, French Polynesia (Not_yet_recruiting)
- Hôpital Uturoa — Uturoa, French Polynesia (Not_yet_recruiting)
Study contacts
- Principal investigator: Betty LIMIER — Institut Curie
- Study coordinator: Betty LIMIER
- Email: betty.limier@curie.fr
- Phone: +33 1 44 32 43 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.