Health Condition 1: D699- Hemorrhagic condition, unspecified
Conditions
Interventions
Intervention1: SERASEAL: Dose 3000 IU per mL, Route Topical, Frequency at the site of bleeding during surgical procedure, Duration Up to 72 Hr post procedure
Control Intervention1: Nil: Nil
Sponsors
Swath kare
Wortham Laboratories Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Written informed consent obtained 2.Men and women, adults, and pediatrics aged newborn or older. 3.Able and willing to comply with the procedures required by the protocol. 4.The subject must complete all screening/ preoperative evaluations. 5.The subject must present an intra-operative bleeding site which has not been previously treated with any standard surgical method to control bleeding. 6.The subject on antithrombotic therapy (warfarin, heparin, aspirin, clopidogrel). (Acceptable clotting time for patients on Warfarin: PT 7.Participants must be able to participate for the 72 hr duration of the study.
Exclusion criteria
Exclusion criteria: 1.The presence of the hemostatic procedures (cautery, staple gun, suture, hemostat) will not be allowed at the primary bleeding site for the duration of the primary endpoint evaluation period of the investigational product. 2.Any clinically infected wound, draining pus, surrounding erythema or edema, or patients with systemic signs of infections. 3.The subject on antibiotic therapy prior to enrollment. 4.The subject known to be pregnant or lactating. 5.The subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry. 6.The subject is scheduled to undergo any surgical procedure other than the surgery which the subject is being treated under this protocol within 14 days prior to treatment. 7.Subjects with complicated diseased conditions. 8.Active hepatic disease (persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal). 9.The subject has an anticipated life expectancy of 10.Inability to return for a 30-day follow-up visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to achieve hemostasis (cessation of bleeding) after SeraSeal applicationTimepoint: The bleeding site will be evaluated at 1, 4, 7, 10, 120 mins & 8, 36, 72 hours after applying the hemostatic agent at the target site. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients achieving hemostasis within a specified time frame. 2.Incidence of rebleeding within a specified time frame after hemostasis is achieved. 3.Rate of treatment failure, defined as need for additional hemostatic interventions. 4.Adverse events related to the use of the SeraSeal, such as local irritation or allergic reactions. 5.Duration of hemostasis after SeraSeal application. 6.Blood loss volume during & after procedure. 7.Time to ambulation or discharge from the hospital. 8.Patient satisfaction with the SeraSeal as a hemostatic agent. 9.Cost-effectiveness analysis comparing the use of the SeraSeal to standard hemostatic methods. 10.Wound healing assessment, including the presence of infections or complications Timepoint: The bleeding site will be evaluated at 1, 4, 7, 10, 120 mins & 8, 36, 72 hours after applying the hemostatic agent at the target site. | — |
Countries
India
Contacts
Public ContactAjaypal randhawa
Swath kare
Outcome results
None listed