NCT05297513

Brief Summary

This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for phase_4

Timeline
2mo left

Started Jul 2022

Longer than P75 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2022Jul 2026

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

March 17, 2022

Last Update Submit

March 30, 2022

Conditions

Spinal Stenosis LumbarSurgical Site InfectionBack Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (1)

  • 90-day surgical site infection

    90 days

Secondary Outcomes (2)

  • Fascial defects at 3-6 months for fusion cases

    6 months

  • Improvement in back and leg pain

    6 months

Study Arms (2)

Standard treatment, no intervention

NO INTERVENTION

Standard treatment, plus ActiveMatrix

EXPERIMENTAL
Drug: ActiveMatrix

Interventions

ActiveMatrixDRUG

All patients will receive weight based prophylactic antibiotics i.e. Ancef, vancomycin, or clindamycin. Drains will be used in fusion cases only. Intrawound vancomycin will be used for all instrumented cases.No negative pressure devices will be used. Anatomic layers will be closed in similar, standard fashion for all cases. For those randomized to the treatment group, the ActiveMatrix product will be administered on top of the dura mater and again on the closed fascia. Those in the control group, will forgo this step.

Standard treatment, plus ActiveMatrix

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, ≥ 18 years of age to 100 years of age
  • Have a clinical diagnosis of thoracic and or lumbosacral spinal disease indicated for decompression and/or fusion
  • Have no contraindications or allergies to the treatment administered

You may not qualify if:

  • Subject is involved with a worker's compensation, personal injury, or other legal matters related to their health
  • Subject does not provide full consent
  • Known history of allergy to allografts
  • Pregnancy or lactation
  • Minimally invasive spinal surgery
  • Non-fusion instrumented cases requiring drains
  • There is no intended distribution or restriction of subjects by racial and ethnic origin. No vulnerable subjects are included in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Casper DS, Zmistowski B, Hollern DA, Hilibrand AS, Vaccaro AR, Schroeder GD, Kepler CK. The Effect of Postoperative Spinal Infections on Patient Mortality. Spine (Phila Pa 1976). 2018 Feb 1;43(3):223-227. doi: 10.1097/BRS.0000000000002277.

    PMID: 28604484BACKGROUND

  • Badiee RK, Mayer R, Pennicooke B, Chou D, Mummaneni PV, Tan LA. Complications following posterior cervical decompression and fusion: a review of incidence, risk factors, and prevention strategies. J Spine Surg. 2020 Mar;6(1):323-333. doi: 10.21037/jss.2019.11.01.

    PMID: 32309669BACKGROUND

  • Melzer AC, Pinsker EA, Clothier B, Noorbaloochi S, Burgess DJ, Danan ER, Fu SS. Validating the use of veterans affairs tobacco health factors for assessing change in smoking status: accuracy, availability, and approach. BMC Med Res Methodol. 2018 May 11;18(1):39. doi: 10.1186/s12874-018-0501-2.

    PMID: 29751746BACKGROUND

  • Agha Z, Lofgren RP, VanRuiswyk JV, Layde PM. Are patients at Veterans Affairs medical centers sicker? A comparative analysis of health status and medical resource use. Arch Intern Med. 2000 Nov 27;160(21):3252-7. doi: 10.1001/archinte.160.21.3252.

    PMID: 11088086BACKGROUND

  • O'Toole JE, Eichholz KM, Fessler RG. Surgical site infection rates after minimally invasive spinal surgery. J Neurosurg Spine. 2009 Oct;11(4):471-6. doi: 10.3171/2009.5.SPINE08633.

    PMID: 19929344BACKGROUND

  • Irvin J, Danchik C, Rall J, Babcock A, Pine M, Barnaby D, Pathakamuri J, Kuebler D. Bioactivity and composition of a preserved connective tissue matrix derived from human placental tissue. J Biomed Mater Res B Appl Biomater. 2018 Nov;106(8):2731-2740. doi: 10.1002/jbm.b.34054. Epub 2018 Feb 13.

    PMID: 29437272BACKGROUND

Related Links

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Neurosurgery BCM

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share