absorbable gelatin compressed sponge, USP

Action and Spectrum

Actions and Spectrum: 

gelatin compressed sponge acts as a hemostatic agent, assisting in the control of bleeding. When the sponge comes into contact with blood or body fluids, it absorbs and swells, forming a gel-like matrix. This matrix helps create a mechanical barrier and provides pressure to the bleeding site, forming a stable blood clot and promoting hemostasis. 

gelatin compressed sponge has a broad spectrum of applications in various surgical specialties, including general surgery, cardiovascular surgery, neurosurgery, orthopedics, and ENT (ear, nose, and throat) surgery. It effectively controls bleeding in different anatomical regions and surgical sites, including surface and deep wounds. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Hives  

Difficult breathing  

Abscess formation  

Blood clots  

Foreign body reaction 

Fluid encapsulation 

Swelling on lips/face/tongue/throat 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

Contraindicated in people with: 

• Allergy to porcine collagen 
• Coagulopathy 
• Bleeding disorders 

Cautions 

• Infection 
• Postpartum bleeding 
• Avoid over-compression 
• Use sterilized products 
• Once used, they cannot be sterilized again 

Pregnancy / Lactation

Pregnancy consideration:  

gelatin compressed is well absorbed topically, but its effect on pregnant females is unknown 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

An absorbable compressed gelatin sponge acts as a hemostatic agent, meaning it promotes blood clotting and helps control bleeding. When the sponge comes into contact with blood or body fluids, it absorbs them, swells, and forms a gel-like matrix. This matrix can help create a mechanical barrier and apply pressure to the bleeding site, forming a stable blood clot.  

Pharmacodynamics: 

The pharmacodynamic effects of gelatin-compressed sponge are primarily localized to the application site. Its actions include promoting hemostasis, providing mechanical support, and facilitating tissue regeneration. These effects are confined to the specific area where the sponge is placed. 

gelatin compressed sponge is designed for localized use, and its systemic absorption is minimal. Therefore, it does not exert significant systemic pharmacodynamic effects. 

Pharmacokinetics: 

• Absorption: compressed gelatin sponge is designed to be absorbable. Over time, the sponge undergoes enzymatic degradation and is gradually absorbed by the body. The absorption process occurs as the body’s enzymes break down the gelatin material, leading to its gradual degradation and replacement by newly formed connective tissue. 
• Biodegradation: The biodegradation of a gelatin-compressed sponge is an essential aspect of its pharmacokinetics. As the sponge biodegrades, it is replaced by the body’s natural healing processes, including forming granulation tissue and collagen deposition. The biodegradation rate depends on various factors, such as the size of the sponge, the site of application, and the individual patient’s healing capacity. 
• Clearance: Since compressed gelatin sponge is primarily absorbed and biodegraded locally at the application site, no significant systemic clearance or elimination process is involved. The body’s natural healing processes gradually replace the remnants of the sponge, and any remaining residue is usually minimal. 
• Systemic Absorption: gelatin compressed sponge is not intended for systemic absorption or distribution throughout the body. Its effects are localized to the specific area where it is applied, and significant systemic absorption is unlikely. 

Adminstartion

Administration: 

Ensure that the gelatin-compressed sponge is sterile and intact before use. Follow the manufacturer’s instructions for proper storage and handling of the product. If necessary, moisten the sponge with sterile saline or other suitable solution as directed. Prepare the site of application by cleaning and disinfecting it according to standard aseptic techniques. Remove any excess blood or debris from the area. 

Place the gelatin-compressed sponge directly onto the bleeding or surgical site. The sponge can be cut or shaped to fit a specific area. Apply gentle pressure to ensure good contact between the sponge and the site. Additional sponges can be applied layer by layer to achieve adequate hemostasis or wound coverage if required. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: absorbable gelatin compressed sponge USP 

Pronounced: ab-zorb-abel gel-a-tin kuhm-presst spuhnj 

Why do we use absorbable gelatin compressed sponge? 

The primary use of an absorbable gelatin-compressed sponge is to promote hemostasis, which means it helps control bleeding. When applied to a bleeding site, the gelatin sponge absorbs blood and forms a gel-like matrix. This matrix helps create a mechanical barrier, provides pressure to the site, and supports the formation of a blood clot, aiding in the cessation of bleeding. 

gelatin compressed sponge has a broad range of applications in various medical specialties, including general surgery, neurosurgery, cardiovascular surgery, orthopedics, and more.