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Assessing the Effect of the Silver Dressing on Surgical Site Infections in Adult Patients Post Cardiac Surgery: a Single Center Randomized Control Trial

K

King Faisal Specialist Hospital & Research Center

Status

Invitation-only

Conditions

Surgical Site Infections
Surgical Site Infection After Major Surgery

Treatments

Other: Silver dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT07008040
Research Ethics Committee (Registry Identifier)
RAC2024-14
RAC 2024-14 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

145 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

145 participants in 1 patient group

Mepilex Border Opsite dressing
Other group
Description:
Only foam dressing used in this arm
Treatment:
Other: Silver dressing

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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