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Oxidized regnerated cellulose: Drug information

Oxidized regnerated cellulose: Drug information
For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Interceed;
  • Surgicel;
  • Surgicel Fibrillar;
  • Surgicel Nu-Knit;
  • Surgicel SNoW 1"x2";
  • Surgicel SNoW 2"x4";
  • Surgicel SNoW 4"x4"
Pharmacologic Category
  • Hemostatic Agent
Dosing: Adult

Hemostasis: Topical:

Interceed: Following hemostasis, apply in single layer on and between raw (denuded) surfaces.

Surgicel: Minimal amounts in appropriate size of cellulose are laid or applied to the bleeding site or held firmly against the tissues until hemostasis occurs; remove excess material.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Pad, External:

Interceed: (10 ea)

Surgicel Fibrillar: (10s, 24s)

Surgicel Nu-Knit: (10s, 24s)

Surgicel SNoW 1"x2": (10 ea)

Surgicel SNoW 2"x4": (10 ea)

Surgicel SNoW 4"x4": (10 ea)

Powder, Absorbable:

Surgicel: 3 g (5 ea)

Generic Equivalent Available: US

No

Administration: Adult

Topical: Note: Also refer to manufacturer's labeling for detailed administration instructions.

Adhesion barrier (Interceed): Place into surgical area as directed.

Pad (Surgicel): May be sutured or cut without fraying.

Powder (Surgicel): Powder is dry; precise delivery under certain circumstances may be difficult. Do not trim applicator tip (applicator tip not intended for laparoscopic or other endoscopic use).

Use: Labeled Indications

Hemostasis (Surgicel): Adjunctive use in surgical procedures to control capillary, venous, or small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.

Pelvic adhesion reduction (Interceed): Adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<1%, postmarketing, and/or case reports: Application site burning, application site edema (encapsulation), blindness (when placed in anterior cranial fossa), difficulty in micturition (after prostatectomy), foreign body reaction, headache, neurotoxicity, paralysis, postoperative complication (adhesions; prolonged drainage after cholecystectomy), sneezing (epistaxis and rhinological procedures), stinging sensation, ureteral obstruction (after kidney resection), vascular insufficiency (stenosis when applied as a wrap)

Contraindications

Interceed: Infection.

Surgicel: Implantation into bone defects (eg, fractures); hemorrhage from large arteries or veins; nonhemorrhagic oozing; use as an adhesion prevention product; intraluminal procedures or use in open blood vessels. Note: Multiple products are available and contraindications may vary by product; also refer to manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Foreign body reactions: Have occurred. Remove excess product before surgical closure to facilitate absorption and reduce risk.

• Pain/numbness/nerve damage/paralysis: Pain, numbness, nerve damage, and paralysis have been reported if used near a bony or neural space and/or the optic nerve and chiasm; use minimum amount necessary to achieve hemostasis.

Dosage forms specific issues:

• Powder: Unintentional placement may result in powder scattering and device migration that may increase the risk of adhesion formation. Do not use in conjunction with autologous blood salvage circuits (fragments may pass through the transfusion filters of blood-scavenging system).

Other warnings/precautions:

• Appropriate use (Interceed): Not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed. Safety and effectiveness in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical procedures have not been established. Also refer to manufacturer's labeling for additional warnings/precautions.

• Appropriate use (Surgicel): The material should not be moistened before insertion since the hemostatic effect is greater when applied dry. The material should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances. Remove as much of agent as possible with sterile water or saline solution after hemostasis is achieved. Do not leave in a contaminated or infected space without drainage. Always remove completely following hemostasis if applied in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chasm; product may swell and exert unwanted pressure. Although packing or wadding sometimes is medically necessary, cellulose should not be used in this manner, unless it is to be removed after hemostasis is achieved. In urological procedures, care must be exercised to prevent plugging of the urethra, ureter, or a catheter. In otorhinolaryngologic surgery, ensure that the material is not aspirated by the patient (eg, controlling hemorrhage after tonsillectomy and controlling epistaxis). In cauterized areas, absorption could be prevented in chemically cauterized areas; cellulose use should not be preceded by application of silver nitrate or any other escharotic chemicals. Also refer to manufacturer's labeling for additional warnings/precautions.

Metabolism/Transport Effects

None known.

Drug Interactions

Silver Nitrate: May diminish the therapeutic effect of Cellulose (Oxidized Regenerated). Risk X: Avoid combination

Reproductive Considerations

Information related to the use of topical hemostatic agents in gynecologic surgery is limited and use should be restricted to situations where preferred interventions are not ideal or are unsafe (ACOG 2020).

Interceed is approved for use as an adjuvant in open (laparotomy) gynecologic pelvic surgery to reduce the incidence of postoperative adhesions. Pelvic adhesions may be associated with pain and infertility; however, it is not clear if use of cellulose (oxidized regenerated) improves fertility or decreases pain (Ahmad 2020; ASRM/SRS 2019).

Surgicel is approved to control hemostasis associated with surgery and may be useful in gynecologic surgeries such as conization of the cervix, hysterectomy, and oophorectomy.

Pregnancy Considerations

Information related to the use of topical hemostatic agents in gynecologic surgery is limited and use should be restricted to situations where preferred interventions are not ideal or are unsafe (ACOG 2020). Interceed has been evaluated for the prevention of intraperitoneal adhesions associated with cesarean delivery (Chapa 2011; Rottenstreich 2020). Use of Surgicel as adjunctive treatment of hemorrhage at the cesarean incision site has been described (Sharma 2006).

Mechanism of Action

Cellulose, oxidized regenerated is saturated with blood at the bleeding site and swells into a brownish or black gelatinous mass which aids in the formation of a clot. When used in small amounts, it is absorbed from the sites of implantation with little or no tissue reaction. In addition to providing hemostasis, oxidized regenerated cellulose also has been shown in vitro to have bactericidal properties. Its hemostatic effect is not enhanced by the addition of thrombin.

REFERENCES

  1. Ahmad G, Kim K, Thompson M, et al. Barrier agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2020;3(3):CD000475. doi:10.1002/14651858.CD000475.pub4 [PubMed 32199406]
  2. American College of Obstetricians and Gynecologists (ACOG). Topical hemostatic agents at time of obstetric and gynecologic surgery: ACOG committee opinion, number 812. Obstet Gynecol. 2020;136(4):e81-e89. doi:10.1097/AOG.0000000000004104 [PubMed 32976379]
  3. Chapa HO, Venegas G, Vanduyne CP, Antonetti AG, Sandate JP, Silver L. Peritoneal adhesion prevention at cesarean section: an analysis of the effectiveness of an absorbable adhesion barrier. J Reprod Med. 2011;56(3-4):103-109. [PubMed 21542525]
  4. Interceed (oxidized regenerated cellulose) [prescribing information]. Somerville, NJ: Ethicon Inc; March 2017.
  5. Larsson B. Efficacy of Interceed in adhesion prevention in gynecologic surgery: a review of 13 clinical studies. J Reprod Med. 1996;41(1):27-34. [PubMed 8855073]
  6. Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society of Reproductive Surgeons. Electronic address: [email protected]; Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society of Reproductive Surgeons. Postoperative adhesions in gynecologic surgery: a committee opinion. Fertil Steril. 2019;112(3):458-463. doi:10.1016/j.fertnstert.2019.06.027 [PubMed 31446904]
  7. Rottenstreich M, Rotem R, Hirsch A, et al. The use of absorbable adhesion barriers to reduce the incidence of intraperitoneal adhesions at repeat cesarean delivery. Arch Gynecol Obstet. 2020;302(1):101-108. doi:10.1007/s00404-020-05591-6 [PubMed 32415470]
  8. Sharma JB and Malhotra M, "Successful Management of Uterine Incision Hemorrhage in Caesarean Section With Topical Oxidized Regenerated Cellulose (Surgicel Nu Knit): A Case Report," Arch Gynecol Obstet, 2006, 274(2):115-6. [PubMed 16408181]
  9. Surgicel Original, Nu-Knit, and Fibrillar (oxidized regenerated cellulose) [prescribing information]. Somerville, NJ: Ethicon US LLC; October 2018.
  10. Surgicel Powder (oxidized regenerated cellulose) [prescribing information]. Somerville, NJ: Ethicon Inc; March 2019.
  11. Surgicel SNoW (oxidized regenerated cellulose) [prescribing information]. Somerville, NJ: Ethicon Inc; November 2019.
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