A Study to Evaluate the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment.
 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is ≥ 18 and ≤ 75 years old.
  • Subject is scheduled for an elective spinal procedure that will require a planned durotomy.
  • Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation is encountered).
  • Subject is able and willing to provide informed consent and HIPAA authorization.
  • Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.

Intra-Operative Inclusion Criteria:

  • Subject has durotomy edges that can be re-approximated using the investigator’s standard methods of dural repair.

Exclusion Criteria:

  • Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
  • Subject has a pre-existing external lumbar CSF drain or internal CSF shunt.
  • Subject has experienced previous CSF leak (secondary to trauma, neoplasm, surgery or other etiology).
  • Subject is undergoing a Chiari malformation procedure.
  • Subject has undergone a previous spinal procedure in the same anatomical location.
  • Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure.
  • Subject has spinal metallic implants that may cause significant imaging artifact on the MRI evaluation of the spine.
  • Subject has metallic implant(s) that are not MRI compatible; e.g., cochlear implant, neurostimulator, stent, surgical clip, cardiac pacemakers, or other non-MRI compatible implants, or an elective implant of such devices is planned during the course of the study. Note: mercury amalgam dental fillings or similar metallic dental prostheses are not an exclusion criterion.
  • Subject has a known malignancy or another condition with anticipated survival shorter than six months.
  • Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or chemotherapy treatment is planned within two weeks after the index procedure is performed.
  • Subject has been treated with chronic steroid therapy (defined as regular (daily) administration of steroid agent(s) for ≥ 8 weeks) unless discontinued greater than four weeks prior to the planned index procedure. Note: standard acute perioperative steroids are permitted; administration of steroid agents for < 8 weeks duration prior to the planned index procedure is permitted.
  • Subject has received warfarin, heparin, other anticoagulant agents, aspirin or non-steroid anti-inflammatory agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
  • Subject has a compromised immune system or autoimmune disease or is on chronic immunosuppressant agents at baseline.
  • Subject has a systemic infection or evidence of any infection near planned operative site.
  • Subject has a serum creatinine level > 2.0 mg/dL.
  • Subject has a serum total bilirubin > 2.5 mg/dL at baseline.
  • Subject has uncontrolled diabetes as evidenced by an HbA1c > 7% prior to surgery.
  • Subject has a known allergy to FD&C Blue #1 and/or FD&C Yellow #5 or any of the constituents of the dural sealants.
  • Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
  • Subject is participating in a clinical trial of another investigational drug or device and has not completed the required follow-up period.

Intra-Operative Exclusion Criteria:

  • Subject has an incidental finding that meets any pre-operative exclusion criterion listed above.
  • Subject’s dural defect cannot be closed with suture and/or duraplasty material.
  • Subject has a gap > 2 mm present between dural edges, or between the edge of dura and duraplasty material, based on visual estimate by surgeon before application of the surgical sealant.
  • Subject had undergone laminoplasty decompression.
  • Subject had undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Benjamin Elder, M.D., Ph.D.

Open for enrollment

Contact information:

Adam Loudermilk

(507) 422-0718

Loudermilk.Adam@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Kaisorn Chaichana, M.D.

Contact us for the latest status

Contact information:

Rosita Almira

Almira.Rosita@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20513570

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