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

NYU Langone Health

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Drain Site Complication

Interventions

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement DressingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Change in Erythema Measurement

Drain site erythema will be measured with a ruler, in millimeters.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 0, up to Month 6

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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