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Completed

NCT Number: NCT06464354

Comparison of the Mammary Harvesting Technique

The skeletonization technique of left internal artery (LIMA) harvesting is reported as more spar-ing to the vascular supply of the sternum. Some studies report a greater length and greater flow of the graft additionally. The aim of our study was to measure the difference in post-op sternal blood supply compared to the pedicle harvesting technique and to measure the length and flow of the LIMA graft.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ostrava

Ostrava, Moravial-Silesian Region, 70852, Czechia

About this study

A total of 90 patients were examined in a prospective randomized study. In 60 patients referred for coronary artery bypass grafting (CABG), LIMA was harvested, one-half (n=30) skeletonized, and one-half (n=30) with a pedicle. Thirty patients operated via sternotomy without LIMA harvesting (other procedures, for instance, valve surgery) were the control group. In patients undergoing LIMA harvest, harvest duration, graft length, and graft free flow were measured at defined arterial pressure. In all patients, the sternal blood flow was examined by active dynamic thermography (DIRT): first preoperatively and on 4th postoperative day. During this, the time of spontaneous rewarming of the skin surface after the application of a cold stimulus was measured in the caudal part of the sternum. The difference between postoperative and preoperative time was calculated and compared between groups.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cardiac surgery procedure via median sternotomy
  • The left mammary artery (LIMA) harvesting for coronary bypass planned as a part of the operation - Group 1 and 2
  • Other cardiac surgery procedures without the LIMA harvesting (valve surgery for instance) - Control group
  • Signing of the informed consent

Exclusion criteria

  • Emergent surgery
  • Re-operation
  • Re-sternotomy
  • Thoracotomy approach
  • Harvesting of both mammary arteries (BIMA)
  • Endocarditis
  • Ongoing non-cardiac infection
  • Fever
  • Circulatory failure
  • Ongoing administration of catecholamines to patient
  • Unsigned informed consent

Treatment and study plan

The mammary artery harvesting by the pedicle technique

Procedure

The mammary artery harvesting by the pedicle technique was used in the LIMA pedicle study group.

The mammary harvesting using the skeletonization technique

Procedure

The mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group.

No intervention

Procedure

No intervention was used in the control study group.

Primary outcomes

  1. Rewarming time difference

    Time frame: first preoperatively and on 4th postoperative day

    Duration of spontaneous rewarming of the skin surface of the caudal sternum after a cold stimulus, measured from 24°C to 27°C. Unit: seconds (s)

Secondary outcomes

  1. Duration of the mammary graft harvesting

    Time frame: during surgery, immediately after the graft harvesting

    Time from the start of the harvesting to complete graft release. Unit: minute (min).

  2. Length of the mammary artery graft

    Time frame: during surgery, immediately after the graft harvesting

    Length from the distance of the graft from the chest wall to its distal end. Unit: millimeter (mm).

  3. Free outflow of the mammary artery

    Time frame: during surgery, just before the graft use

    After trimming the distal clip on the graft at an arterial pressure of 70 mmHg, free flow for 30 seconds, then multiplied by two. Unit: millilitre per minute (ml/min).

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

Comparison of the Effect of Mammary Artery Harvesting Technique to Sternal Blood Supply Using Non-contact Dynamic Thermography

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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