Shockwave Intervention for Enhanced Wound Healing in No-touch Pedicle Saphenous Vein Graft Harvesting for Coronary Artery Bypass Grafting

We defined the occurrence of a wound healing complication as followed:

Definition of Surgical Site Infection (SSI)

The SSI definition is in accordance with the guidelines of the center for disease control and their recommendations for superficial incisional SSI:

• Date of event occurs within 30 days following the operative procedure AND involves only skin and subcutaneous tissue of the incision AND
• Patient has at least one of the following:

• Purulent drainage from the superficial incision
• Organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment
• Superficial incision that is deliberately opened by a sur

Difference in the Bates-Jensen Wound Assessment Tool (BWAT) score. The BWAT is a validated instrument used to assess wound healing, consisting of 13 scored items related to wound size, depth, edges, undermining, necrotic tissue, exudate, skin color, peripheral tissue, granulation, and epithelialization. Each item is scored from 1 (best) to 5 (worst). The total score ranges from 13 (completely healed wound) to 65 (most severe wound condition). Higher scores indicate worse wound status.

Difference in the EQ-5D-5L index score, a standardized measure of health-related quality of life developed by the EuroQol Group. The EQ-5D-5L index score ranges from -0.594 to 1.000, where higher scores indicate better health status. A score of 1 represents full health, 0 represents a health state equivalent to death, and negative values represent health states considered worse than death.

Number of unscheduled outpatient visits

Rate of surgical revisions due to wound healing complications, except for bleeding

Proportion of patients requiring antibiotics due to wound healing complications

Wound status at discharge Difference in the Bates-Jensen Wound Assessment Tool (BWAT) score. The BWAT is a validated instrument used to assess wound healing, consisting of 13 scored items related to wound size, depth, edges, undermining, necrotic tissue, exudate, skin color, peripheral tissue, granulation, and epithelialization. Each item is scored from 1 (best) to 5 (worst). The total score ranges from 13 (completely healed wound) to 65 (most severe wound condition). Higher scores indicate worse wound status.

Difference in laboratory values:

• HbA1c
• Creatinin
• Total Cholesterol
• LDL-C
• HDL-C
• Lp(a)
• LDH,
• Erythrocytes,
• Haemoglobin
• Haematocrit
• Platelet count
• Leukocytes
• CRP,
• APTT,
• INR
• NT-pro-BNP
• Total CK
• CK-MB
• CK-MB %
• Troponin T

Device related adverse events A clinical trial adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in a patient or clinical trial subject C or not related to the investigational medical device. This includes events related or not to a comparator and procedures involved.

Surgical procedures themselves are not AEs; they are therapeutic measures for conditions that require surgery. The condition for which the surgery is required may be an AE. Planned surgical measures permitted by the clinical trial protocol and the condition(s) leading to these measures are not AEs, if the condition leading to the measure was present prior to inclusion into the trial.

Device related Serious Adverse Events

• death (excluding death from progressive disease)
• a life-threatening experience - refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe
• initial hospitalization, or prolongation of existing inpatients hospitalization
• persistent or significant disability or incapacity
• congenital anomaly or birth defect
• occur a malignant tumor