Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Jazz Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients > 18 years

Patient receiving:

• Conditioning of autologous bone marrow transplantation by high dose melphalan (HD) as part of the management of myeloma or BEAM in lymphoma.

• A conditioning allogeneic bone marrow transplantation with reduced or intermediate busulfan IV

• Patients belong to a schema of social security, having signed the written informed consent.

Exclusion Criteria:

• patients:

• To receive or have received KGF

• With previous history of RT with the exception of patients who received spinal analgesic therapy in the treatment of myeloma

• Unable or unwilling to complete the self assessment questionnaire

• With previous history of allergy to any component of the products under consideration

• Minor

• Adults under guardianship

• Pregnant women

• Patients who have not signed the consent form

• Creation of mouthwash out of the study