Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04258878
Other study ID # periop- RFs in cardiac surgery
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date April 30, 2022

Study information

Verified date February 2020
Source Assiut University
Contact Mohammed Hussein Rushdi, Dr
Phone 201124239591
Email mhrd2017@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

We aim to prospectively evaluate the risk factors that can play a role before, during or after the surgical period.


Description:

Surgical site infections (SSIs) are either superficial or deep and may involve the organs, or spaces accessed during an operation. The reported incidence of SSIs in coronary artery bypass grafting (CABG) surgery ranges between 0.3% and 8%.

There is a strong suggestion that an impairment of vascular supply of the sternum may be one of the most important factors influencing the incidence of deep sternal wound infection (DSWI). Several studies have studied the risk factors for SSIs including DSWI in cardiac surgery. These risk factors included obesity, diabetes mellitus, chronic obstructive pulmonary disease (COPD), connective tissue disease, steroid use, smoking, peripheral vascular disease and renal insufficiency. In addition, intraoperative factors (e.g., use of bilateral internal mammary arteries [BIMA] grafting, prolonged cardiopulmonary bypass [CPB] duration) and postoperative variables (e.g., prolonged mechanical ventilation, reoperation for bleeding, postoperative transfusions and gastrointestinal, nephrological and respiratory complications) have been shown to be associated with DSWI.

The risk for sternal wound infection (SWI) is increased if cardiac surgery involves internal thoracic arteries grafting and a valve procedure, or use of a ventricular assist device.

Leg wound infections at donor sites account for >70% of cases with severe infection following cardiac surgery.

Cardiac SSIs increase the length of hospital stay (LOS) and increase treatment costs in proportion to the severity of the infection. These costs increase by 3.8%, 14.7% and 29.4% in mild, moderate and severe infections respectively.

Treatment is often confounded by the emergence of antibiotic-resistant pathogens and in addition, substantial proportions of these infected patients are elderly and have co-existing medical problems. In the past, such elderly patients with significant comorbidities would not have been considered for surgery.[8] As the population ages, it is reasonable to assume that older and sicker patients will be admitted for surgery, and this will inevitably increase the risk and incidence of SSIs.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date April 30, 2022
Est. primary completion date March 29, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility IInclusion Criteria:

1. patient aged more than 18 yards old

2. sternotomy for: coronary artery bypass,

Exclusion Criteria:

1. patient under age or 18years old.

2. patient who has endocarditis.

3. patient who underwent surgery with prothetic material, within the 12 months preceeding cardiac procedure.

Study Design


Intervention

Procedure:
Sternotomy
Procedure: Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary surgical wound infection Evaluate the duration of complete healing of the sternum :By
Radiological (chest x-ray ant-post view and lat view in first 3 weeks post-operative
Clinical examination in first 3 weeks post operative
baseline
Secondary Evaluation of perioperative risk factors for surgical wound infection in cardiac surgery Evaluate rate of wound infection in first 3 weeks post operative
-Evaluate the improvement in symptoms of patients postoperative: By
pain by pain score in first 3 week post operative
regain normal activity in first 3 week post operative
baseline
See also
  Status Clinical Trial Phase
Completed NCT05529173 - Povidone-Iodine for Nasal Decolonization Phase 4
Recruiting NCT03295955 - Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy N/A
Not yet recruiting NCT05276687 - Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection Phase 4
Completed NCT02776774 - Topical Antibiotic Treatment for Spine Surgical Site Infection
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Completed NCT03148067 - Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT01890720 - Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section N/A
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2
Completed NCT02919410 - Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial N/A
Completed NCT02020018 - Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection N/A
Completed NCT01741649 - Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section N/A
Not yet recruiting NCT01457859 - Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery Phase 4
Completed NCT01340534 - Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection Phase 3
Completed NCT03365219 - Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections N/A
Completed NCT01026259 - Local Warming of Surgical Incisions Phase 3
Completed NCT03574090 - Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery Phase 4
Completed NCT03199911 - Topical Antibiotic Prophylaxis for Eyelids Phase 4