The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection
- Conditions
- Drain Site Complication
- Interventions
- Device: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing
- Registration Number
- NCT04656145
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chlorhexidine Gluconate Gel Dressing 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing All subjects are receiving two surgical drains during a single operative procedure. This arm will be randomized to receive the intervention.
- Primary Outcome Measures
Name Time Method Change in Erythema Measurement Day 0, up to Month 6 Drain site erythema will be measured with a ruler, in millimeters.
Number of participants in each category of skin induration (flat, soft, or firm) up to Month 6 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.
Total amount of drainage from drain site Up to Month 6 Amount of drainage from drain site will be measured in cubic centimeters.
Number of participants who experience pain post-op Up to Month 6 5. Pain will be measured by asking patients if they experience pain (yes or no) when the clinician presses on the drain site.
Number of participants in each category of quality of drainage (serous, sanguineous, or purulent) Day 0, up to Month 6 Quality of drainage will be assessed by measuring thickness of drainage. Thickness of drainage will be measured as serous, sanguineous, or purulent.
Change in distance between skin changes and normal looking skin Day 0, up to Month 6 Extent of skin changes is measured using a ruler, in millimeters, to calculate the distance between skin changes and normal looking skin.
- Secondary Outcome Measures
Name Time Method Number of participants displaying presence of hematoma up to Month 6 Number of participants displaying sterility of seroma up to Month 6 Sterility of seroma will be measured by assessing whether the serous collection of fluid has absence of infection.
Number of participants displaying signs of wound infection up to Month 6 Measures of wound infection will be assessed by documenting any signs of cellulitis or abscess around the drain.
Antibiotic prescription rate up to Month 6 This will be measured as the number of days that patients are prescribed antibiotics.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States