Health Condition 1: L949- Localized connective tissue disorder, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Aegis Lifesciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder Timepoint: Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemostatic Handling Characteristics (Surgeon s Questionnaire) Time Frame Day 0 Surgery Determination of handling characteristics of absorbable gelatine sponge and powder during implantation Liquefication Time Frame Day 5 post procedure Determination of initiation of absorption of absorbable gelatine sponge and powder through radiological examination after 5 days of its implantation Absorption Time Frame Day 28 post procedure] Determination of complete absorption of absorbable gelatine sponge and powder through radiological examination after 28 days of its implantation Determination of safety Time Frame Procedure up to 60 days post procedure] Evaluation of rate of incidence due to the implantation of absorbable gelatine sponge and powder Timepoint: Day 0 Day 5 Day 28 Day 60 | — |
Countries
India
Contacts
Public ContactAtonu Dutta
Alceon Medtech Consulting
Outcome results
None listed