A clinical study to evaluate safety and performance of absorbable, gelatin-based hemostat in patients undergoing different types of surgeries.
- Conditions
- Health Condition 1: L949- Localized connective tissue disorder, unspecified
- Registration Number
- CTRI/2024/01/061742
- Lead Sponsor
- Aegis Lifesciences Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. The patient is 18 years of age or older
2. The patient will undergo one or more of the following procedures: abdominal, anorectal, dental, ENT, Genito-urinary,gynecological, hysterectomy, neurosurgery, orthopaedic, otolaryngological, partial nephrectomy, plastic surgery, cardiovascular, spinal, tumor surgery, hepatic or ophthalmic surgery
3. Patient or their guardian is willing to sign Informed Consent Form (ICF)
4. Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up
Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care) or is lactating
Patient is allergic to collagen derived products or any other materials used in absorbable gelatine sponge and powder
Patient has an active infection at the surgical site
The use of hemostat is contraindicated for the patient
Patient has known bleeding disorder (including thrombocytopenia (less than 100000 platelet count) thrombasthenia hemophilia or von Willebrand disease)
Patient has received antibiotic solutions or powders at the intended application site
Patient has undergone surgery at the intended application site less than or equal to 6 months before the current surgical procedure
Patient is unavailable for followup
Patient is currently participating in another clinical study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery <br/ ><br>Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder <br/ ><br>Timepoint: Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery <br/ ><br>Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder <br/ ><br>
- Secondary Outcome Measures
Name Time Method Hemostatic Handling Characteristics (Surgeon s Questionnaire) Time Frame Day 0 Surgery <br/ ><br>Determination of handling characteristics of absorbable gelatine sponge and powder during implantation <br/ ><br>Liquefication Time Frame Day 5 post procedure <br/ ><br>Determination of initiation of absorption of absorbable gelatine sponge and powder through radiological examination after 5 days of its implantation <br/ ><br>Absorption Time Frame Day 28 post procedure] <br/ ><br>Determination of complete absorption of absorbable gelatine sponge and powder through radiological examination after 28 days of its implantation <br/ ><br>Determination of safety Time Frame Procedure up to 60 days post procedure] <br/ ><br>Evaluation of rate of incidence due to the implantation of absorbable gelatine sponge and powder <br/ ><br>Timepoint: Day 0 Day 5 Day 28 Day 60