Clinical trial NCT04743895: Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone
Official title: Randomized, Single Blinded Pilot Study of Stainless Steel Wire Cerclage Versus FiberTape® Cerclage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sternotomy
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Single Blinded Study
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility 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).

Primary outcomes:
measure: Progression of sternal healing
timeFrame: 3 months post-operative
Secondary outcomes:
measure: Complication rate
timeFrame: Collected at Immediate post-operatively, again at 3 weeks, 6 weeks, 3 months, 6 months
measure: Visual Analog Scale (VAS)
timeFrame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
measure: Veteran's Rand Health Survey
timeFrame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
measure: Analgesic medication Log
timeFrame: Collected at immediate post-operatively during hospital stay, again at 3 weeks, 6 weeks, 3 months and 6 months.
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Lee Memorial Health System
state: Florida
Study officials:
References: