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Study team was not able to enroll eligible patients.
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This study aims to evaluate if the application of chlorhexidine gluconate dressing on surgical drain sites can decrease drain site infection vs the standard of care (dry, sterile gauze).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine Gluconate Gel Dressing | Experimental | All subjects are receiving two surgical drains during a single operative procedure. This arm will be randomized to receive the intervention. |
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| Standard of Care | No Intervention | All subjects are receiving two surgical drains during a single operative procedure. This arm will be randomized to received standard drain care - gauze (no intervention). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing | Device | On the day of the operation, after the procedure has concluded and the drains have been placed, the surgical drain site that has been randomized to be in the experimental group will receive the chlorhexidine gel dressing. The dressing will remain on the patient until the drain has been removed and the surgical site will be assessed for signs of infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erythema Measurement | Drain site erythema will be measured with a ruler, in millimeters. | Day 0, up to Month 6 |
| Number of participants in each category of skin induration (flat, soft, or firm) | 2. Induration of skin will be measured by palpation of the skin around the drain by the clinician. This will be measured by assessing whether skin is flat, soft, or firm. | up to Month 6 |
| Change in distance between skin changes and normal looking skin | Extent of skin changes is measured using a ruler, in millimeters, to calculate the distance between skin changes and normal looking skin. | Day 0, up to Month 6 |
| Total amount of drainage from drain site | Amount of drainage from drain site will be measured in cubic centimeters. | Up to Month 6 |
| Number of participants who experience pain post-op | 5. Pain will be measured by asking patients if they experience pain (yes or no) when the clinician presses on the drain site. | Up to Month 6 |
| Number of participants in each category of quality of drainage (serous, sanguineous, or purulent) | Quality of drainage will be assessed by measuring thickness of drainage. Thickness of drainage will be measured as serous, sanguineous, or purulent. | Day 0, up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants displaying signs of wound infection | Measures of wound infection will be assessed by documenting any signs of cellulitis or abscess around the drain. | up to Month 6 |
| Number of participants displaying sterility of seroma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Chiu, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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A paired study design will be used and subjects will serve as their own control.
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Sterility of seroma will be measured by assessing whether the serous collection of fluid has absence of infection.
| up to Month 6 |
| Antibiotic prescription rate | This will be measured as the number of days that patients are prescribed antibiotics. | up to Month 6 |
| Number of participants displaying presence of hematoma | up to Month 6 |