Health Condition 1: Z480- Encounter for attention to dressings, sutures and drains
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The Subject must be treated with PINION PDO suture with a soft suture approximation procedure. 2. The Subject must be willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) or Ethics Committee approved Informed Consent form 3. In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting. If the Subject is not able to write on behalf of the Subject, the Subjects LAR Legally acceptable representative can fill out the informed consent. 4. Subject must be willing to undergo soft tissue repair and be able to undergo all other study procedures as outlined in this protocol. 5. The subject is willing and able to comply with postoperative scheduled clinical evaluations
Exclusion criteria
Exclusion criteria: Participants are not suitable for anesthesia or endovascular surgery, such as those with severe respiratory, heart, lung, liver, kidney disease or coagulation disorders such as hemophilia. Participants undergoing neural tissue procedures and tendinous tissue repair or surgery. Participants scheduled for ophthalmic surgery and microsurgery. Participants undergoing urinary tract and biliary tract surgery where prolonged contact with salt solutions is anticipated. Participants with a history of HIV or any other systemic infections. Participants with ongoing sepsis or septicemia, ongoing bacterial infection or on antibiotic treatment other than prophylaxis antibiotics given prior to and post-surgery. Participants with a history of prior surgery within the past one month with Surgical Site Infection. Pregnant or breast-feeding women. Participants who are unwilling or unable to sign the Informed Consent Document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Surgical site infection 2.wound complications 3.Adverse event 4.Intraoperative complicationsTimepoint: 1. Time Frame: Intra-operative 2.Time Frame: Intra-operative 3.Time Frame: 7 days 2 days, 30 days 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Length of hospital stay 2.Re-admission rate 3.Ease of UseTimepoint: 1.Time Frame: Post-operative , 7 days 2 days, 30 days 7 days, 3 months 15 days & 6 months 30 days 2.Time Frame: Intra-operative 3.Time Frame: Discharge, 7 days 2 days,30 days 7 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed