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

NCT04656145 | Withdrawn FDA Device

• 1 other identifier: 20-01587
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Drain Site Complication

Keywords

Tegaderm

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Number of participants displaying signs of wound infection

  up to Month 6

• Number of participants displaying sterility of seroma

  up to Month 6

• Antibiotic prescription rate

  up to Month 6

• Number of participants displaying presence of hematoma

  up to Month 6

Study Arms (2)

Chlorhexidine Gluconate Gel Dressing

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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).

Interventions

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

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.

Chlorhexidine Gluconate Gel Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• David Chiu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A paired study design will be used and subjects will serve as their own control.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: January 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)