Clinical trial NCT04656145: The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection
Official title: The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Drain Site Complication
Keywords: Tegaderm
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A paired study design will be used and subjects will serve as their own control.
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. 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:

1. Concurrent implantation of any foreign objects, such as a breast implant
2. Patients who receive postoperative antibiotics without a suspected or identified site of infection
3. 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.

Primary outcomes:
measure: Change in Erythema Measurement
timeFrame: Day 0, up to Month 6
measure: Number of participants in each category of skin induration (flat, soft, or firm)
timeFrame: up to Month 6
measure: Change in distance between skin changes and normal looking skin
timeFrame: Day 0, up to Month 6
measure: Total amount of drainage from drain site
timeFrame: Up to Month 6
measure: Number of participants who experience pain post-op
timeFrame: Up to Month 6
measure: Number of participants in each category of quality of drainage (serous, sanguineous, or purulent)
timeFrame: Day 0, up to Month 6
Secondary outcomes:
measure: Number of participants displaying signs of wound infection
timeFrame: up to Month 6
measure: Number of participants displaying sterility of seroma
timeFrame: up to Month 6
measure: Antibiotic prescription rate
timeFrame: up to Month 6
measure: Number of participants displaying presence of hematoma
timeFrame: up to Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References: