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 are willing to be treated with the FILAXYN AB Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P for use in general soft tissue approximation, including use in pediatric cardiovascular tissue and ophthalmic surgery (Other than contact with cornea and sclera). 2. Subjects enroll both men and women and all general population adults of all age groups for soft tissue approximation and/or ligation. 3. Pediatric subjects with cardiovascular and ophthalmic surgery (other than contact with cornea and sclera). 4. Subjects must be 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. 5.The subject is not able to write on behalf of the Subject, the Subject s LAR (Legally acceptable representative) can fill out the informed consent. 6. Subject is willing and able to comply with scheduled postoperative clinical evaluations.
Exclusion criteria
Exclusion criteria: 1. Subjects who are not treated with the FILAXYN AB Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P. 2. Adult Subjects who require cardiovascular, microsurgery, and neurological tissue surgeries, FILAXYN AB Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P. 3. FILAXYN AB Absorbable Poly(P-Dioxanone) Surgical Suture U.S.P cannot be used in direct contact with the heart,the central circulatory system, or the central nervous system. 4. Subjects who have known allergic reactions to Triclosan. 5. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Superficial Surgical site infection 2.Surgical Suture success 3.Adverse Events or Adverse Reactions or Complications related to SutureTimepoint: 1.Time Frame: Through discharge, 7 days, 15 days, 1 month, 3 months 2.Time Frame: Through discharge, 7 days, 15 days, 1 month, 3 months 3.Through discharge, 7 days, 15 days, 1 month, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Triclosan resistance to pathogens 2.Bacterial selection & microscopic characterization 3.Wound Healing Grade 4. Postoperative pain score 5. Re admission & Reoperation due to SSI related complications 6. Ease of useTimepoint: Intra operative, Through discharge, 7 days, 15 days, 1 month, 3 month | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed