MREC Reviewer Comment
Protocol Title
Bioactive porous hydrogel based on dicalcium silicate/chitosan/polyvinyl pyrrolidone loaded with gentamicin for bone regeneration and osteomyelitis treatment
Completely satisfied and informative data
Needs Explanation
Comments to the applicant
1- The title should be modified (misleading) to express that the preparation maybe a potential treatment
2- The primary and secondary objectives should be revisited
3- Study sample size and statistical procedures needs further clarification (significance level, samples per each group, etc) as well as the power calculations.
4- Further clarification about the usage of gentamicin is needed in study procedures
Comment to the Committee
Informed consent form:
Waiver
