Health Condition 1: T07- Unspecified multiple injuries
Conditions
Interventions
Intervention1: StopBleed hemostatic dressing: StopBleed hemostatic dressing
will be applied on the wound for a minimum of 2 minutes and a maximum of 30 minutes. Hemostasis will be assessed
based on t
Sponsors
Miraqules MedSolutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: Adults aged 18 to 60 years. 2. Wound characteristics: Subjects with Wounds in scalp, upper and lower extremities at the time of baseline assessment with: 3. Mild diffuse bleeding OR Moderate to severe bleeding with bleeding site less than 10 cm2 According to a validated bleeding scale. 4. Subjects or their legal representative who is willing to provide informed consent as approved by the IRB/IEC to participate.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of study is time taken to achieve hemostasis in the bleeding wound. It is the summation of the total time spent on compressing the wound to achieve haemostasis. Primary safety endpoint of this study is the occurrence of secondary ooze of blood after the dressing is being removed as per the IFU.Timepoint: 1. 2 Minutes (Primary Efficacy End points) 2. 2 Minutes (Primary safety end point) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Volume of blood loss for each group during assessment of hemostasis via gravimetric evaluation. 2. Number of Applications (StopBleed or Gauze) required to achieve hemostasis. 3. Rebleeding & time & frequency of occurrence within 30 minutes after initial cessation of bleeding. 4. Adverse events related to treatment (StopBleed or control) application till 30 days via a passive follow up. Timepoint: 1. 30 Mins 2. 48 Hours 3. 30 Days | — |
Countries
India
Contacts
Public ContactKaushik M Gawali
Sanjay Gandhi Institute of Trauma and Orthopaedics
Outcome results
None listed