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

NYU Langone Health

Status: Withdrawn

Conditions: Drain Site Complication

Treatments: Device: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04656145

20-01587

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Chlorhexidine Gluconate Gel Dressing

Experimental group

Description:

All subjects are receiving two surgical drains during a single operative procedure. This arm will be randomized to receive the intervention.

Treatment:

Device: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing

Standard of Care

No Intervention group

Description:

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).