Enrolling by invitation NCT07008040

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

No phase Interventional Surgical Site Infection After Major Surgery Surgical Site Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Silver dressing.
Who it may be relevant to: Registry conditions: Surgical Site Infection After Major Surgery, Surgical Site Infections. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Saudi Arabia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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.

Interventions

Other Silver dressing
Silver dressing will be applied to the sternotomy and donor site wounds for the CABG patients

Primary outcome measures

silver dressing on SSI rates as compared to the standard dressing- Mepilex foam dressing in reducing SSIs. [Time frame: 30 days post op]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Prevention

Study locations

Saudi Arabia · 1 center

King Faisal Specialist Hospital and Research Center - Jeddah — Jeddah

Publications

Dissemond J, Bottrich JG, Braunwarth H, Hilt J, Wilken P, Munter KC. Evidence for silver in wound care - meta-analysis of clinical studies from 2000-2015. J Dtsch Dermatol Ges. 2017 May;15(5):524-535. doi: 10.1111/ddg.13233. PMID 28485879

Identifiers

NCT: NCT07008040 · RAC2024-14 · RAC 2024-14 · Research Ethics Committee

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗