The objective of the present study was to study the impact of insulin insitu-gel formulation on healing progress after surgical procedures for treatment of dry tympanic membrane perforation for at least three consecutive months. At the beginning, an insulin insitu-gel was prepared from three different polymers compatible with insulin physiochemically and reported to be vain on insulin efficacy or safety. Insulin insitu-gel was prepared using chitosan, polyvinyl alcohol, and Pluronic F127 with glycerol as a penetration enhancer. Selection of an optimized formulation through in situ gel characterization and in vitro drug release kinetics then the formulation was evaluated for healing efficacy on human volunteers in RCT. A randomized controlled clinical study was implemented for clinical evaluation of insitu-gel formulation activity in the Department of Otorhinolaryngology, Minia University Hospital, from January 2025 to March 2026. Perforation healing signs as a primary indicator was followed and reported in three follow-up visits (1 week, 1 month, and 2 months) in addition hearing score pre- and post-surgery as secondary outcomes. Results of a clinical study showed that the healing is significantly superior in the insulin group than in the control group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
insulin was formulated as insitu gel
Plain foam
Minia university hospital
Minya, Egypt
Perforation size
endoscopic otoscopy, with graft uptake classified as complete, partial, or failed/reperforated
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.