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

Drain Site Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04656145
• Other study ID #: 20-01587
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: July 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drain Site Complication
• Infections

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Erythema Measurement	Drain site erythema will be measured with a ruler, in millimeters.	Day 0, up to Month 6
Primary	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
Primary	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
Primary	Total amount of drainage from drain site	Amount of drainage from drain site will be measured in cubic centimeters.	Up to Month 6
Primary	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
Primary	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	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
Secondary	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
Secondary	Antibiotic prescription rate	This will be measured as the number of days that patients are prescribed antibiotics.	up to Month 6
Secondary	Number of participants displaying presence of hematoma		up to Month 6