Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: ZIP-STITCH SURGICAL WOUND CLOSURE DEVICE: ZIP-STITCH SURGICAL WOUND CLOSURE DEVICE IN THE CLOSURE OF UNCONTAMINATED MINOR LACERATION
Intervention2: Zip-Stitch Surgical Wound Closure Dev
Sponsors
Simplified Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with Low Tension Laceration 2. Requires suture closure as the standard of care for simple straight wounds on trunk extremities or face. 3. Patients who provide a agree to abide by the study requirements
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women 2. Known personal or familial history of scar hypertrophy 3. Known or suspected allergies or hypersensitivity to materials used in device 4. Atrophic skin deemed clinically prone to blistering. 5. Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions contaminated/dirty wounds 6. Wounds that require deep dermal closure using sutures. 7. Known or suspected psychological problems or aggressiveness that indicates that the subject might try to remove the device during the treatment period. 8. Ongoing treatment with cytostatic. 9. Known or suspected diagnosis of severe anorexia. 10. Currently participating or have participated in any other clinical investigation in the past 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean Change in Wound Evaluation Scale on Day 3, Day 5, Day 7 and Day 10 visit when compared to baseline visit. 2. Time taken for wound healing 3. Ability to eliminate scarTimepoint: Day3, 5,7 and 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in pain Day 3, Day 5, Day 7 and Day 10 visit when compared to baseline visit as assessed by VAS 2. Mean Change in Investigators wound healing assessment scale on Day 3, Day 5, Day 7 and Day 10 visit when compared to baseline visit. 3. Mean Change in Patient wound healing assessment scale on Day 3, Day 5, Day 7 and Day 10 visit when compared to baseline visit. 4. Number of Adverse Events reported 5. Percentage of patients with adverse eventsTimepoint: 10 up to 14 days | — |
Countries
India
Contacts
Public ContactDisha Shetty
Samahitha Research Solutions
Outcome results
None listed