King Faisal Specialist Hospital and Research Center - Jeddah
Jeddah, Saudi Arabia
NCT Number: NCT07008040
RCT on post-cardiac surgery patients using silver dressings vs. standard care. Conducted in ICU, CCU, telemetry units. Outcomes assessed via checklist & modified Parsonnet Score. Descriptive & inferential statistics for analysis.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Jeddah, Saudi Arabia
Background The prevalence of surgical site infections in cardiac surgery is about 10%. About 3% of patients who develop an SSI will die as a result. Multiple studies confirm that SSIs are complications with significant sequelae, such as longer hospitalization, increased health costs, increased morbidity, and mortality. Hence, the prevention and management of wound infections in median sternotomy incisions after adult cardiac surgery are crucial for optimizing patient outcomes, 5 Aim To assess the effect of the silver dressing on SSI rates in adult patients post-cardiac surgery.
Methodology A single-center randomized control trial approach will be employed. Adult patients admitted post-cardiac surgery with a sternotomy incision will be randomized into the intervention (n=78) or control group (n=77). Units will include the cardiac surgical intensive care unit, the coronary care unit, and the cardiovascular telemetry unit. The intervention will include the use of a silver dressing on the sternotomy incisions and the donor sites where applicable. The control group will follow standard care processes. Data collection will include a checklist and the modified Parsonnet Score. Data analysis will include descriptive and inferential statistics.
Conclusion The current rate of surgical site infection amongst cardiac surgical patients is 2.1 below the benchmark of 2.9 with an operational goal of 2.1.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients 18 years of age and older are scheduled for cardiac surgery requiring a sternotomy incision.
Exclusion criteria
Presence of a concurrent infection and any systemic antibiotic other than those used for perioperative prophylaxis.
Patients who died without an infection within thirty days following surgery. Patients who had undergone another procedure through the same incision(s) within a year after enrollment in this study.
Patients who are a redo- such as needing debridement or an infection. Patients who have an open chest Patients on ECHMO Patients excessively bleeding Patients who require the surgery as an emergency Patients with a known allergy to silver dressings
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Silver dressing will be applied to the sternotomy and donor site wounds for the CABG patients
Time frame: 30 days post op
King Faisal Specialist Hospital & Research Center
Other
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