A study to test the efficacy and safety of the Zip-stitch device in patients with minor lacerations
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/09/046040
- Lead Sponsor
- Simplified Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method