Surgical Site Infection After Major SurgeryNCT07008040
Assessing the Effect of the Silver Dressing on Surgical Site Infections in Adult Patients Post Cardiac Surgery: a Single Center Randomized Control Trial
A study testing Silver dressing in people with Surgical Site Infection After Major Surgery and Surgical Site Infections, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection After Major Surgery, Surgical Site Infections
- What is being tested?
- Silver dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Center - Jeddah
Jeddah
About this study
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.
Read the 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.
- Being tested
- Silver dressing
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver dressingOther
Silver dressing will be applied to the sternotomy and donor site wounds for the CABG patients
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Border Opsite dressing | Other | Only foam dressing used in this arm Receives: Other: Silver dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
silver dressing on SSI rates as compared to the standard dressing- Mepilex foam dressing in reducing SSIs.
Measured: 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection After Major SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control and intervention group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer De Beer, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008040
- Sponsor's protocol ID
- RAC2024-14
- Other IDs
- RAC 2024-14, Research Ethics Committee
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared due to privacy concerns and institutional policies.
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.
PubMed 28485879
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of the Silver Dressing on Surgical Site Infections in Adult Patients Post Cardiac Surgery: a Single Center Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07008040
- Acronym / sponsor ID
- RAC2024-14
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- control and intervention group
| Arm | Type | Receives |
|---|---|---|
| Mepilex Border Opsite dressing | Other | Other: Silver dressingOnly foam dressing used in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver dressingSilver dressing will be applied to the sternotomy and donor site wounds for the CABG patients | Other | Mepilex Border Opsite dressing |
Primary outcome
silver dressing on SSI rates as compared to the standard dressing- Mepilex foam dressing in reducing SSIs.
Time frame: 30 days post op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 28485879Dissemond 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.
- Individual participant dataSharing planned: No. The data will not be shared due to privacy concerns and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver dressing in people with Surgical Site Infection After Major Surgery and Surgical Site Infections, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
silver dressing on SSI rates as compared to the standard dressing- Mepilex foam dressing in reducing SSIs. (time frame: 30 days post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07008040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.