Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Romo Vac Set (GS-5002, GS-5002F, GS-5002M, GS-5002S, GS-5002N), Mini Vac Set (GS-5006), Flat Drain Set (GS-5047), Redon Drain Catheter (GS-5004): Device maximum use duration is not more
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and Females Adult & Paediatric who are expected to undergo surgery closed wound drainage procedures 2 The subject who is willing and able to comply with the requirement of the follow-up OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who is willing and able to comply with the requirement of the follow-up. 3 Subject who can provide Informed Consent Form Adult in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics parent of child LAR Legally Acceptable Representative can provide Informed Assent Form Child
Exclusion criteria
Exclusion criteria: 1 Subject who present with medical emergency where treatment is more priority than the informed consent process informed assent process 2 Subject who cannot provide Informed Consent Form Adult such as unconscious mentally challenged subject OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who cannot provide Informed Assent Form Child or give permission etc 3 Any known allergy with any of the material of Closed Wound Drainage System and its components 4 Other conditions which in the opinion of investigators make the patient unsuitable for enrollment or could interfere with his her participation in and completion of the clinical investigation plan protocol 5 Subject who is pregnant or breastfeeding 6 Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital 7 Participation in another research study involving an active investigation within 30 days prior to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary End Point of the study are as 1 Intended for Closed Wound Drainage 2 Facilitating drainage from the Closed wound site by catheter 3 Angulated sharp tipped trocar needle for easy penetration and placement of drainage catheter 4 Application of optimum negative pressure by flexible bellow jar chamber 5 Facilitating the precise drained volume determination in follow-up from closed wound 6 Improving the quality of life by reduction of symptoms 7 Achieving the intended clinical purposeTimepoint: Device maximum use duration is not more than 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary End Point of the study are as 1 Device material compatibility with the tissue and body fluids 2 Durability Sustainability of device during placement & intended clinical performance 3 Proper fixation fitment of the device accessoriesTimepoint: Device maximum use duration is not more than 7 days | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed