SURGICEL® Powder Absorbable Hemostat

The next generation of the #1 brand of absorbable adjunctive hemostats is built to stop continuous, broad-surface oozing fast—even on friable or raw tissues.1,2

SURGICEL Powder Absorbable Hemostat

Features & Benefits

  • Gets to the source of the bleed

    Gets to the Source of the Bleed1,3

    The structure of the powder penetrates the surface of the blood.1,3 Blood saturates the material, providing a surface for platelet adhesion and aggregation, and initiating clot formation.1,3

  • Adherent Hemostasis

    Adherent Hemostasis

    Efficiently and effectively controls bleeding. After hemostasis has been achieved, the source will not rebleed even if SURGICEL Powder is irrigated.2 SURGICEL Powder efficiently and effectively controls continuous oozing on broad surfaces and fully absorbs within 7 to 14 days.4, 5

  • Proven bactericidal

    Proven Bactericidal6-8

    Bactericidal against the top five hospital-acquired pathogens.6-8 Localized reduction in blood pH results in bactericidal activity against a broad range of gram-positive and gram-negative organisms, including antibiotic-resistant bacteria.6-8

  • SURGICEL® Powder

    SURGICEL® Powder
     

    Named a “Gold Winner" in the “Drug-Delivery Devices and Combination Products” by the Medical Design Excellence Awards.

Product Specifications

Product Code

Product Code

Description

 
3013SP 3013SP Oxidized Regenerated Cellulose (ORC) powder 

Product Resources

Resources

SURGICEL Powder Overview Video

Supporting Documentation

Clinical Support

SURGICEL® Compendium of Scientific Literature

Product Support

SURGICEL Powder Sales Aid

Biosurgery Non-Clinical Portfolio Sales Aid

Biosurgery Portfolio

SURGICEL Family Always Prepared

References

1. Data on file, Ethicon. Powder TTH vs Original Final Report. 2015.

2. Data on file, Ethicon. Final Report, PSE Accession No. 16-0006. Project No. 16438.

3. Data on file, Ethicon. METHOD, Surface Energy/Tension Analysis.

4. Data on file, Ethicon. Acceptability and Absorbability of Surgicel. 1995.

5. Data on file, Ethicon. Acceptability and Absorbability of Surgicel and Surgicel Nu-Knit. 1993.

6. Spangler D, Rothenburger S, Nguyen K, Jampani H, Weiss S, Bhende S. In vitro antimicrobial activity of oxidized regenerated cellulose against antibiotic-resistant microorganisms. Surg Infect. 2003;4(3):255-262.

7. Dineen P. Antibacterial activity of oxidized regenerated cellulose. Surg Gynecol Obstet. 1976;142(4):481-486.

8. Data on file, Ethicon. Surgicel Powder IFU.

9. Patsalos C, Karavias D, Stavropoulos M, et al. The relationship between five kinds of laparoscopic knots and five types of suture materials and histological findings in tissues: an experimental study on rabbits. Surg Laparosc Endosc Percutan Tech. 2003;13(3):202-207.

SURGICEL® Powder Absorbable Hemostat Essential Product Information

  • INDICATIONS

SURGICEL® Powder (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.

  • CONTRAINDICATIONS

Do not inject or place SURGICEL® Powder into an open blood vessel. Do not use to treat bleeding from large defects in arteries or veins.

SURGICEL® Powder should not be used to control hemorrhage from large arteries or veins.

When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.

SURGICEL® Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation.

  • WARNINGS

Closing with SURGICEL® Powder in a contaminated wound without drainage may lead to complications and should be avoided.

SURGICEL® Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances. 

SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation. 

Although SURGICEL® Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections.

Do not attempt to trim the applicator tip.

  • PRECAUTIONS

SURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems.

Use only as much SURGICEL® Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction.

In urological procedures, minimal amounts of SURGICEL® Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

Since absorption of SURGICEL® Powder could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

If SURGICEL® Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis).

This applicator tip is not intended for laparoscopic or other endoscopic use.

  • ADVERSE EVENTS 

Paralysis and nerve damage have been reported when other SURGICEL® products were used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. 

Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when other SURGICEL® products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS).

Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats.

Burning has been reported when other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported.

For more information and technical questions, call 1-800-795-0012.  For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert.

071582-180827