Fort Myers, Florida 33908

  • Sternotomy

Purpose:

This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.


Study summary:

The primary objective of this study is to evaluate the progression of sternal healing in subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire. The secondary objectives are to evaluate the complication rate and postoperative pain of subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire. CT scans are performed at three months postoperatively to assess sternal healing. Two radiologists will read all CT scans. Axial slices are analyzed at five locations along the sternum (manubrium, top of the aortic arch, aortopulmonary window, main pulmonary arteries, and aortic root) using a 6-point quantitative scale (0=no sign of healing, 1=minimal healing, 2=mild healing, 3=moderate healing, 4=partial synthesis, 5=complete synthesis). All adverse events related to the sternal closure procedure or the devices used for closure will be collected. Postoperative pain scores will be collected using a 10 cm visual analog scale (VAS) with a numeric rating of 0 to 10. Sternal pain will be rated at rest, coughing, and with movement. Postoperative analgesic use for sternal closure pain will be evaluated.The Veterans Rand (VR-12) health survey will be collected postoperatively (see schedule of events for details).


Criteria:

Inclusion Criteria: 1. The subject is age 18 or over. 2. The subject has a planned full median sternotomy. 3. The subject has the ability to read, understand and sign the written informed consent document and complete the online surveys. Exclusion Criteria: 1. The subject is having a re-operative sternotomy. 2. The subject is having an emergency or salvage operation. 3. The subject has an unplanned sternotomy incision. 4. The subject had an incomplete sternotomy. 5. The subject has chronic pain syndromes or chronic narcotic administration. 6. The subject has a history of chest irradiation. 7. The subject is unwilling to comply with study follow-up visits and surveys. 8. The subject has a sternal infection or suspected sternal infection. 9. The subject has any known comorbidity that will influence the outcomes. 10. The subject is considered vulnerable (i.e. prisoner, child, pregnant, handicapped, or mentally disabled person).


NCT ID:

NCT04743895


Primary Contact:

Kelly Ganz, BA
Phone: (800) 933-7001
Email: kelly.ganz@arthrex.com


Backup Contact:

Email: Alicia.ruiz@arthrex.com
Alicia Ruiz
Phone: (800) 933-7001


Location Contact:

Fort Myers, Florida 33908
United States

Michelle Deckard

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.