drugset / Trial / NCT05297513
Efficacy of ActiveMatrix on Spinal SSI Rate
Phase 4
Not yet recruiting
275 enrolled
Baylor College of Medicine
Skye Biologics Holdings, LLC · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
This clinical trial seeks to provide high level of evidence on the efficacy of ActiveMatrix primarily on spinal surgical site infection rate.
Timeline
- Start
- 2022-07
- Primary completion
- 2025-07
- Completion
- 2026-07
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ActiveMatrix | Other / unclassified | — | Topical |