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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| University of California, San Francisco | OTHER |
| University of Massachusetts, Amherst | OTHER |
| Hoag Memorial Hospital Presbyterian |
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The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) is a two-arm multi-center individual placebo-controlled randomized (2,700 participants randomized 1:1) clinical trial to reduce post-discharge surgical site infection following open colon or small bowel surgery by comparing chlorhexidine bathing plus nasal mupirocin in the 30 days following discharge to soap without antiseptic properties (placebo) and placebo nasal ointment. This trial seeks to enhance the care of the 675,000 patients annually who undergo colon and small bowel surgery by finding simple and efficacious interventions to reduce SSI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decolonization | Active Comparator | Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin). |
|
| Routine Care | Placebo Comparator | Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% Chlorhexidine Gluconate | Drug | Used for daily showering/bathing for 30 days after hospital discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Post-Discharge Surgical Site Infection | Within 30 Days of Hospital Discharge |
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Inclusion Criteria:
Exclusion Criteria:
Transfer to an acute care hospital
Discharged to receive end-of-life hospice measures
Discharged more than 14 days after surgery
Allergic to mupirocin and/or chlorhexidine
Active infection at enrollment*
*Refers to
Surgical incision not closed at discharge
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Huang, MD, MPH | Contact | (949) 824-5073 | sshuang@hs.uci.edu | |
| Raveena Singh, MA | Contact | (949) 824-9285 | ravsingh@hs.uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Susan Huang, MD, MPH | University of California, Irvine | Principal Investigator |
| Deborah Yokoe, MD, MPH | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
A data request form will be provided to any researcher requesting data from the DECREASE SSI trial This data request form will request the hypothesis/goal of the research, the planned use of the data, and the requested data elements (deidentified only). Any data provided will include the stipulation that use is limited to research purposes only. Requests will not be granted for pursuits directly specified in the grant. If the data request overlaps with additional ongoing post-grant pursuits either by this team or another investigative team that requested the data for a given purpose, a discussion will be pursued toward the potential for joint collaboration.
3 years from publication
Pending
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| OTHER |
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| 2% Mupirocin | Drug | Applied to each nostril twice daily for five days for the first two weeks after hospital discharge. |
|
| Soap Without Antiseptic Properties (Placebo) | Drug | Used for daily showering/bathing for 30 days after hospital discharge. |
|
| Placebo Nasal Ointment | Drug | Applied to each nostril twice daily for five days for the first two weeks after hospital discharge. |
|
| Stuart Cohen, MD |
| University of California, Davis |
| Study Director |
| University of California, Irvine Medical Center | Recruiting | Orange | California | 92868 | United States |
|
| University of California, Davis Medical Center | Recruiting | Sacramento | California | 95817 | United States |
|
| University of California, San Francisco Medical Center | Recruiting | San Francisco | California | 94143 | United States |
|
| 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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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D016712 | Mupirocin |
| D012915 | Soaps |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003902 | Detergents |
| D013501 | Surface-Active Agents |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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