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| ID | Type | Description | Link |
|---|---|---|---|
| RAC 2024-14 | Other Grant/Funding Number | KFSHRC-J | |
| Research Ethics Committee | Other Identifier | King Faisal Specialist Hospital and Research Center - Jeddah |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Border Opsite dressing | Other | Only foam dressing used in this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver dressing | Other | Silver dressing will be applied to the sternotomy and donor site wounds for the CABG patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| silver dressing on SSI rates as compared to the standard dressing- Mepilex foam dressing in reducing SSIs. | 30 days post op |
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital and Research Center - Jeddah | Jeddah | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28485879 | Background | 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. |
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The data will not be shared due to privacy concerns and institutional policies.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2024 | May 29, 2025 |
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control and intervention group
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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