Effects of Treatments on Atopic Dermatitis
NCT01631617
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dermatitis
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT07158879
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.
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Request Info18 year–100 year
All sexes
Observational
Institut Curie, Paris, France
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:
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 :
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: through study completion, an average of 18 months
correlation between the onset of skin reactions and the treatments administered
Time frame: through study completion, an average of 18 months
Percentage of patients with skin reactions according to the type of dressing used
Time frame: through study completion, an average of 18 months
Percentage of patients with skin reactions according to the immune status (polynuclear/monocytic);
Time frame: through study completion, an average of 18 months
Percentage of patients with skin reactions according to the duration of application of dressing
Time frame: through study completion, an average of 18 months
Evaluation of pain and discomfort experienced by the patient, measured on a numerical scale scale from 0 to 10 (0 = no pain; 10 = very intense pain)
Time frame: through study completion, an average of 18 months
Percentage of patients requiring PAC removal
Time frame: through study completion, an average of 18 months
Percentage of patients with catheter infection
Time frame: through study completion, an average of 18 months
Percentage of patients requiring postponement or cancellation of their chemotherapy
Contact information is provided by the study sponsor or research team.
Betty LIMIER
CONTACT
Isabelle FROMANTIN, Ph.D
CONTACT
Institut Curie
Other
Acronym: KPAREAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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