The Influence of Tantum Verde® on Recovery Following Tonsillectomy

NCT ID: NCT02190162

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-12-01

Brief Summary

The purpose of this study is to assess the effects of Tantum Verde® for improving recovery following tonsillectomy Study design: A prospective double-blined randomized trial. Sample size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be treated with a placebo.

The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign the inform consent in one of two places: in the departments before the surgery or in the clinic in the visit before the surgery. The patients will be evaluated for their ability to gargle and spit water before the surgery, after which they will be assigned to either the treatment group who will get a solution of Tantum Verde or the control group who will receive saline with mint flavor, both in identicle bottles. Randomization will be done using a random number generator program.

The patients will be asked to gargle and spit the solution they received three times a day for 30 seconds, for the following week after surgery.

Conditions

Tonsillectomy; Adenoidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Tantum Verde® mouthwash

solution of Tantum Verde

Group Type: ACTIVE_COMPARATOR

Tantum Verde® mouthwash

Intervention Type: DRUG

placebo mouthwash

saline with mint flavor

Group Type: PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type: OTHER

Mouthwash with placebo solution

Interventions

Tantum Verde® mouthwash

Intervention Type: DRUG

Placebo mouthwash

Mouthwash with placebo solution

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients undergoing tonsillectomy with or without adenoidectomy
• Over 12 years of age
• Signed informed consent by patient or caregiver

Exclusion Criteria

• Inability to gargle and spit
• Allergy to one of the solution ingredients
• Significant comorbidity (e.g. diabetes, bleeding disorders)
• Unable/ unwilling to comply with the protocol requirements
• Pregnancy or breast feeding
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

Withdrawal Criteria:

• Patients did not comply with the protocol requirements

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ronen Ohad

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Galillee medical center

Nahariya, , Israel

Countries

Israel

Other Identifiers

0028-14-NHR

Identifier Type: -

Identifier Source: org_study_id