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

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 Overview

• Status: Withdrawn
• Conditions: Drain Site Complication
• Intervention / Treatment: Device: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine Gluconate Gel Dressing; 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; 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.
No Intervention: Standard of Care; 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?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: David Chiu, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Tegaderm
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 20-01587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes