Skin Reactions Related to Thoracic Implantable Chamber Dressings

Recruiting

• Conditions: Skin Diseases

• Registration Number: NCT07158879
• Lead Sponsor: Institut Curie

Brief Summary

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.

Detailed Description

The Implantable Catheter Chamber (ICC) has been in use since the 1980s. It enables the administration of nutrition and/or venotoxic and cytotoxic treatment without altering the patient's venous capital. In oncology, CCIs account for over 90% of central venous accesses used in France, i.e. some 160,000 installations per year.

However, the use of this type of central line can also expose patients to the risk of complications such as infection, obstruction and extravasation, which, given the high stakes for patients, have led to the prioritization of work on these subjects.

To date, studies have focused almost exclusively on infectious risks, which are the most frequent and have the greatest impact on patients. This work has led to improvements in professional practices, such as covering with a semi-permeable film to control the appearance of infectious signs.

Other problems have emerged, such as skin reactions linked to semi-permeable films. These are defined by the appearance of one or more of the following criteria:

* Persistent redness at the dressing site;

* Itching;

* Dermabrasion.

However, little has been written on this subject. A 10-day observational survey was carried out in our oncology departments in 2023:

45.5% of inpatients and 14% of day-care patients (dressing left in place for a few days versus a few hours) developed this type of cutaneous reaction.

Given the high prevalence of these reactions, we feel it is important to see whether these results are confirmed in a large cohort of patients, and to investigate whether skin tolerance could be linked to :

* Individual factors (gender, age, immune status, history, etc.);

* The treatments administered and their side effects on the skin;

* The semi-permeable film and how it was applied;

* Duration of application;

* climatic conditions. To answer these questions, which could lead to proposals for adjustments to good practice in oncology, we propose to carry out a multicenter cohort study.

The study of cutaneous tolerance to CCI dressings is poorly documented. However, it represents a major challenge, due to the repetition of application and removal procedures, the sometimes prolonged duration of application, and can be the cause of discomfort and pain, which can sometimes be considerable.

The choice of a second center in the French West Indies will enable us to observe the cutaneous reactions of a wide variety of skin types, and to observe whether there are differences according to heat and hygrometry. This is an interesting choice in a context of climate change and population mixing.

This care research is complementary to the medical research carried out on CCI infections.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-10
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-12-10
• Study Completion: 2026-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring the incidence of skin reactions associated with thoracic implantable chamber dressings	through study completion, an average of 18 months	Appearance of itching and/or erythema (defined as diffuse or localized congestive redness of the skin) at the dressing site

Secondary Outcome Measures

Name	Time	Method
Identify risk factors for skin reactions to dressings	through study completion, an average of 18 months	Percentage of patients with skin reactions according to the duration of application of dressing
Estimate the consequences of these reactions in terms of therapeutic management (implementation of a specific skin treatment, postponement or cancellation of chemotherapy), complications (catheter infection), patient comfort and satisfaction.	through study completion, an average of 18 months	Percentage of patients requiring postponement or cancellation of their chemotherapy

Trial Locations

Locations (3)

Institut Curie; 🇫🇷 Paris, France

Centre Hospitalier de Polynésie Française CHPF; 🇵🇫 Pirae, French Polynesia

Hôpital Uturoa; 🇵🇫 Uturoa, French Polynesia