A prospective, single-arm, mono-center, observational post-marketing surveillance study toinvestigate the triclosan-resistant pathogenic colonization on MITSU AB™ absorbable poly(glycolide/L-lactide) triclosan-coated surgical suture U.S.P after soft tissue approximation in areal-world setting - MITSU AB

Meril Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.All consecutive patients who will undergo general soft tissue approximation and or ligation except for ophthalmic, cardiovascular, and neurological tissues.
•2. The Subject must be treated with MITSU AB.
•3. The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
•4. In the case of a Subject and LAR being illiterate a literate impartial witness is required during consenting.
•5. If the Subject is not able to write on behalf of the Subject, the Subjects LAR can fill out the informed consent.
•6.The Subject is willing and able to comply with postoperative scheduled clinical evaluations.
•7. Subjects who are able to give voluntary written informed consent to participate in this clinical investigation and from whom consent has been obtained

•1.The Subject who does not approve the informed consent is not eligible for the study.
•2.MITSU AB absorbable suture is not recommended where an extended approximation of tissues under stress is required.
•3. MITSU AB absorbable suture should not be used in patients having any known sensitivity to suture material, i.e., glycolide, L-lactide, calcium stearate, and triclosan.
•4. Subjects who require surgeries of either ophthalmic, cardiovascular, or central nervous system are not considered for MITSU AB absorbable suture.
•5. Any Subject with an immune compromised medical condition shall not be considered.
•6.The pregnant women shall be excluded.

发起方

Meril Life Sciences Pvt Ltd