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

NCT07008040 | Enrolling By Invitation DMC

• 3 other identifiers: RAC2024-14RAC 2024-14Research Ethics Committee
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Site Infection After Major Surgery; Surgical Site Infections

Outcome Measures

Primary Outcomes (1)

• silver dressing on SSI rates as compared to the standard dressing- Mepilex foam dressing in reducing SSIs.

  30 days post op

Study Arms (1)

Mepilex Border Opsite dressing

OTHER

Only foam dressing used in this arm

Other: Silver dressing

Interventions

Silver dressing OTHER

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

Mepilex Border Opsite dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Center - Jeddah

Jeddah, Saudi Arabia

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: control and intervention group

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)