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

NCT ID: NCT07008040

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Surgical Site Infection After Major Surgery Surgical Site Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

control and intervention group
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mepilex Border Opsite dressing

Only foam dressing used in this arm

Group Type OTHER

Silver dressing

Intervention Type OTHER

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

Interventions

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Silver dressing

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients 18 years of age and older are scheduled for cardiac surgery requiring a sternotomy incision.

Exclusion Criteria

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Jennifer De Beer

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Faisal Specialist Hospital and Research Center - Jeddah

Jeddah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 28485879 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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RAC 2024-14

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Research Ethics Committee

Identifier Type: OTHER

Identifier Source: secondary_id

RAC2024-14

Identifier Type: -

Identifier Source: org_study_id

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