The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection

Study Overview
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Brief Summary
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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).

Official Title
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The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection

Conditions
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Drain Site Complication

Intervention / Treatment
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* Device: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Receiving two surgical drains during one of the following types of operative procedures: breast reduction, breast augmentation, abdominoplasty, panniculectomy, brachioplasty, thigh lift, lower body lift, belt lipectomy, back latissimus dorsi reconstruction, bilateral breast reconstruction, or bilateral chest reconstruction. These drains may be in fairly close proximity to one another but they must emerge from different areas of the skin, that way they can be considered to be located in two different sites. Exclusion Criteria: Concurrent implantation of any foreign objects, such as a breast implant Patients who receive postoperative antibiotics without a suspected or identified site of infection Subjects allergic to or hypersensitive to chlorhexidine gluconate. Before enrolling in the study, patients will be asked about previous exposure to chlorhexidine products and about their allergies. Those with potential allergic or adverse reaction to chlorhexidine will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A paired study design will be used and subjects will serve as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine Gluconate Gel Dressing<br>All subjects are receiving two surgical drains during a single operative procedure. This arm will be randomized to receive the intervention. | Device: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing<br>* 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.<br>|
| No Intervention: Standard of Care<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tegaderm