dextranomer


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dextranomer

 [dek-stran´o-mer]
small beads of highly hydrophilic dextran polymers used in débridement of secreting wounds, such as venous stasis ulcers; the sterilized beads are poured over secreting wounds to absorb wound exudates and prevent crust formation.

dextranomer/hyaluronate

(dex-tran-oh-mer/ hy-al-yoor-on-ate),

Solesta

(trade name)

Classification

Therapeutic: temporary class
Pharmacologic: temporary class

Indications

Management of fecal incontinence in patients who have failed conventional therapy (diet, fiber therapy and/or anti-motility agents.

Action

Dextranomer microspheres act as a bulking agent; hyaluronate provides a viscous vehicle that serves as a carrier to facilitate injection.

Therapeutic effects

Decreased episodes of fecal incontinence.

Pharmacokinetics

Absorption: Provides local effect at injection site
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
rectal submucosal injectionwithin dayswithin days-mos12 mos or more

Contraindications/Precautions

Contraindicated in: Allergy to hyaluronic acid-based products; Active inflammatory bowel disease;Immunodeficiency disorders/immunosuppressant therapy; Previous pelvic radiation; Active anorectal abscesses, fissures, sepsis, bleeding, proctitis or other infections; Anorectal atresia, tumors, stenosis or malformation; Rectocele; Rectal varices; Present existing anorectal implant.
Use Cautiously in: Previous surgical procedures involving the anorectal region, complete anorectal disruption, significant chronic anorectal pain (safety and effectiveness not established); Concurrent anticoagulants or bleeding diatheses (↑ risk of bleeding following procedure); Obstetric: Safety and effectiveness during pregnancy not established); Lactation: Safety and effectiveness during breast-feeding not established); Pediatric: Safe and effective use in children <18 yr not established.

Adverse Reactions/Side Effects

Gastrointestinal

  • constipation
  • defecation urgency
  • diarrhea
  • painful defecation

Genitourinary

  • dyspareunia

Local

  • proctalgia (most frequent)
  • anal fissure
  • anal hemorrhage
  • anal prolapse
  • anal pruritus
  • anorectal discomfort
  • injection site hemorrhage
  • injection site pain
  • proctitis
  • rectal abscess
  • rectal discharge

Miscellaneous

  • chills
  • fever

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Anorectal submucosal injection: (Adults) Four 1 mL injections: posterior, left lateral, anterior and right lateral

Availability

Microspheres in solution for submucosal injection: dextranomer microspheres 50 mg/mL and hyaluronate 15 mg/mL in 1 mL disposable syringe

Nursing implications

Nursing assessment

  • Assess frequency of fecal incontinence before and after therapy.

Potential Nursing Diagnoses

Diarrhea (Indications)

Implementation

  • Dextranomer hyaluronate should only be administered by physicians experienced in performing anorectal procedures and having successfully completed a comprehensive training and certification program in injection procedure.
  • Injections are made in midline of anterior wall of rectum. Use a new needle and syringe with each injection. Hold needle at injection site for additional 15–30 seconds to minimize leakage. May require repeated injections. Avoid in men with enlarged prostate.
    • Do not inject IV; may cause vascular occlusion.
  • Pre-treatment—evacuate rectum with an enema immediately prior injection. Follow by cleansing area with antiseptic. Prophylactic antibiotics are recommended.

Patient/Family Teaching

  • Explain purpose and procedure to patient.
  • Inform patient that dextranomer hyaluronate is not effective for all patients with fecal incontinence and repeat treatment may be required for treatment effect.
  • Explain post-treatment care and potential adverse events to patient.
  • Advise patient that implants might be detected during future anorectal examinations and radiographic imaging of pelvis. Instruct patient to inform all future treating physicians about presence of Solesta gel. If future surgery (e.g., hemorrhoidectomy) is needed Solesta implant can be resected.

Evaluation/Desired Outcomes

  • Fewer episodes of fecal incontinence.
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References in periodicals archive ?
Laberge et al., "Lower esophageal sphincter augmentation by endoscopic injection of dextranomer hyaluronic acid copolymer in a porcine gastroesophageal reflux disease model," Journal of Pediatric Surgery, vol.
Cofer, "Injection pharyngoplasty with a hyaluronic acid and dextranomer copolymer to treat velopharyngeal insufficiency in adults," in Proceedings of the Mayo Clinic Proceedings: Innovations, Quality & Outcomes, vol.
(b) Darkblue/purple dextranomer microspheres and hyaluronic acid (10X).
Endoscopic treatment of Grades IV and V vesicoureteral reflux with two bulking substances: Dextranomer hyaluronic acid copolymer vs.
Efficacy of dextranomer hyaluronic acid and polyacrylamide hydrogel in endoscopic treatment of vesicoureteral relfux: A comparative study.
Dx/HA is a combination of equal parts dextranomer microspheres and sodium hyaluronate.
Randomized clinical trial comparing endoscopic treatment with dextranomer hyaluronic acid copolymer and Cohen's ureteral reimplantation for vesicoureteral reflux: Long-term results.
Lack of distant migration after injection of a 125iodine labeled dextranomer based implant into the rabbit bladder.
Quotations are invited for Supply of Dextranomer Microspheres (Specification A prefilled Syringe of highly A viscous gel of Dextranomer microspheres (50mg/ml) or equivalent in a Carrier gel of non animal stabilized Hyaluronic acid (NASHA gel) or equivalent in a prefilled 1ml syringe to be used as endoscopic injection.
Cystoscopic injections of dextranomer hyaluronic acid into proximal urethra for urethral incompetence: efficacy and adverse outcomes.
40 - dextranomer to endoscopic treatment of VUR- Task No.
DiHA (dextranomers in hyaluronan) injections for treatment of insufficient closure of the vocal folds: early clinical experiences.