Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region.

The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests.

The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmel Medical Center
• Treatments: Picibanil

Criteria

Inclusion Criteria:

• LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.

• ONLY IN THE HEAD AND NECK AREA

• TIME FROM OPERATION AT LEAST 6 MONTHS

Exclusion Criteria:

• penicillin allergy

• pregnancy

• familial history of RF

• Post streptococcal glomerulonephritis

• Background illness-heart, kidney, lungs

• fever > 38.5c in the op day

• URT Infection

• Family history of PANDAS