Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 8. Women who have undergone a Cesarean section and received sutures
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Superficial Surgical site infection (SSI) 2.Triclosan resistance of pathogens 3.Bacterial selection and microscopic characterization 4.Wound Healing GradeTimepoint: 1.Time Frame: Discharge, 7 days, 15 days, 30 postoperatively 2.Time Frame: Discharge, 7 days, 15 days , 30 days post operation 3.Time frame: Discharge, 7days, 15 days, 30 days post operation 4.Time Frame: 7 days, 15 days, 30days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Postoperative incisional pain score (Visual Analogue Scale or VAS) 2.Re-admission due to SSI-related complications 3.Re-intervention due to SSI-related complicationsTimepoint: 1. Time Frame: 7 days, 15 days, 30 days 2.Time Frame: 7 days, 15 days, 30 days 3.Time Frame: 7 days, 15 days, 30 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed