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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
34
Wire cerclage used to close sternum after cardiothoracic surgery.
Lee Memorial Health System
Fort Myers, Florida, United States
Progression of sternal healing
A CT scan will be used to assess sternal healing. Axial slices will be analyzed at 5 locations along the sternum using a 6 point quantitative scale. (0-no healing, 1- minimal healing, 2-mild healing, 3-moderate healing, 4-partial synthesis, 5-complete synthesis).
Time frame: 3 months post-operative
Complication rate
Device related adverse event collection
Time frame: Collected at Immediate post-operatively, again at 3 weeks, 6 weeks, 3 months, 6 months
Visual Analog Scale (VAS)
Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0 being no pain to 10 being worst pain.
Time frame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Veteran's Rand Health Survey
Patient reported physical and mental health survey. Answers are summarized into 2 scores, a physical component score (PCS) and a mental component score (MCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
Time frame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Analgesic medication Log
Analgesic use for sternal pain will be collected on a medication log, tracking type of pain medication, dose and start and ends dates.
Time frame: Collected at immediate post-operatively during hospital stay, again at 3 weeks, 6 weeks, 3 months and 6 months.
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