Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who will undergo general soft tissue approximation and /or ligation. 2.Subject who undergoing treatment of FILAPRON AB(TM) suture. 3.Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form. In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting. 4.Subject is not able to write on behalf of the Subject, the Subject s LAR (Legally acceptable representative) can fill out the informed consent. 5.Subject is willing and able to comply with postoperative scheduled clinical evaluations. 6.Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
Exclusion criteria
Exclusion criteria: 1.Subject who does not able to provide the written informed consent form. 2.Subject for whom absorbable sutures are not recommended or suitable should avoid their use in situations requiring prolonged tissue approximation under stress. 3.FILAPRON AB absorbable suture must not be used for abdominal or facial tissue closure. 4.Subjects with known sensitivity to suture material, i.e., glycolide, caprolactone, and triclosan. 5.Subjects who require surgeries of either ophthalmic, cardiovascular, or central nervous system. 6.Subject with an immune compromised medical condition. 7. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Surgical site infection 2.Adverse events 3.Success rateTimepoint: 1.Time Frame: 7 days, 15days, 30 days and 4 months 2.Time Frame: Through Discharge, 7 days, 15 days, 30 days and 4 months 3.Time Frame: Intra operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Triclosan resistance of pathogens 2.Bacterial selection & microscopic characterization 3.Incisional pain 4.Re admission & Re intervention due to related complications 5.Intra operative suture handling 6.Wound cosmesisTimepoint: 1.Time Frame: Discharge, 7 days, 15 days, 30 days & 4 months post operation 2.Time frame: Discharge, 7 days, 15 days, 30 days & 4 months post operation 3.Time frame: Discharge, 7 days, 15 days, 30 days & 4 months post operation 4.Time Frame: 7 days, 15 days, 30 days & 4 months 5.Time Frame: Intraoperative 6.Time Frame: Discharge, 7 days, 15 days, 30 days & 4 months | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed