Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorPharmaluce srl
About this trial
The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril® Aerosol Combo in its different modalities of use, through the analysis of clinical and subjective outcomes in children operated on adenoidectomy or adenotonsillectomy, compared with a hypertonic solution and an over-the-counter isotonic solution (control group).
The primary question it aims to answer is whether the components prensent in Munatoril provide a benefit and whether they play a role in the recovery of nasal homeostasis following adeinodectomy and adenotonsillectomy compared with an over-the-counter hypertonic saline solution.
Endpoints Evaluation of subjective longitudinal differences (intragroup over-time change) and differences between study group and control group (intergroup difference) regarding the use of the medical device, obtained following the protocol, with assessment at 8, 15 and 30 days after surgery by Likert Scale Score for tolerability, and at 0, 15 and 30 days by SNOT22 Score and Lund-Kennedy Endoscopic Score for efficacy.
In addition, there is a recording of any adverse events in both groups at 8, 15 and 30 days post-surgery, and an inter-group comparative evaluation.
Participants: Pediatric patients who are candidates for adenoidectomy or adenotonsillectomy surgery at the study site facility will be systematically evaluated preoperatively for inclusion in the clinical trial and possibly recruited. Follow-up will last 30 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of either sex aged 2 to 17 years who are candidates for adenoidectomy or adenotonsillectomy surgery.
Acquisition and signing of informed consent by the legal guardian.
Disqualifiers
Syndromic patients.
Patients allergic to any substance in the study formulations.
Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.
Active respiratory infection in the 2 weeks prior to study entry.
Trial design
Design model
Parallel
Treatments tested in this trial
Munatoril Aerosol Combo
DeviceMunatoril® Aerosol Combo is a Medical Device that contains: 5 ml single-dose vials of sterile, 3% hypertonic, near-neutral pH bromine-iodine saline solution, based on Cervia integral sea salt, salso-bromo-iodine saline mother water from the Cervia Thermal Baths and hyaluronic acid with high molecular weight. Lavonase® syringe with blue nebulizer valve (microsol), 10 ml, Medical Device for the administration of solutions in nebulized form within the nasal cavities and nasopharynx.
Iperclenny
DeviceHypertonic and Isotonic solution present on market in italy.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: MunatorilExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Subjective evaluation for efficacy: QoL
The investigator will use the questionnaire "Sino-Nasal Outcome Test-22 (SNOT-22)" for the evaluation of QoL and the symptoms impact on patient's life. The SNOT-22 is based on a Likert scale where 0 = "No problem", 1 = "Very mild problem", 2 = "Mild or slight problem", 3 = "Moderate problem", 4 = "Severe problem", and 5 = "Problem as bad as it can be." Are 22 items and the score can be from 0 to 110. Higher scores means a worse outcome.
Time frame
T0 (preoperative) - T2 (15 days) - T3 (30 days).Secondary outcomes
1
Objective evaluation for efficacy: Lund-kennedy Score
Lund-kennedy Score: This score assesses the severity of three objective data trough nasal endoscopy. It is polyps (0, none; 1, in the middle meatus; 2, beyond the middle meatus); discharge (0, none; 1, clear and thin; 2, thick and purulent); edema (0, absent; 1, mild; 2, severe); scarring/adhesions (0, absent; 1, mild; 2, severe); and crusting (0, absent; 1, mild; 2, severe). The score can be from 0 to 10. Higher scores means a worse outcome.
Time frame
T0 (intraopertory ) - T2 (15 days) - T3 (30 days).Other outcomes
1
Tolerability and recording of any adverse events to assess safety profile
Likert Scale Score from 1 to 5 score. Higher scores means a worse outcome.
Time frame
T1 (8 days - telephone administration) - T2 (15 days) - T3 (30 days).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pharmaluce srl
Lead sponsor
Gruppo FarmaImpresa
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: