Drain Site ComplicationNCT04656145
The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection
A study testing 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing in people with Drain Site Complication, run by NYU Langone Health at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drain Site Complication
- What is being tested?
- 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing
- Keywords
- Tegaderm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erythema Measurement
Drain site erythema will be measured with a ruler, in millimeters.
Measured: Day 0, up to Month 6
Number of participants in each category of skin induration (flat, soft, or firm)
- 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.
Measured: 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.
Measured: 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.
Measured: Up to Month 6
Number of participants who experience pain post-op
- Pain will be measured by asking patients if they experience pain (yes or no) when the clinician presses on the drain site.
Measured: 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.
Measured: Day 0, up to Month 6
Secondary outcomes (4)
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.
Measured: 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.
Measured: up to Month 6
Antibiotic prescription rate
This will be measured as the number of days that patients are prescribed antibiotics.
Measured: up to Month 6
Number of participants displaying presence of hematoma
Measured: up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Why it stopped: Study team was not able to enroll eligible patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drain Site ComplicationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A paired study design will be used and subjects will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Chiu, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656145
- Sponsor's protocol ID
- 20-01587
- Status last verified
- Jul 2023
- First submitted
- 30 Nov 2020
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection
- ClinicalTrials.gov ID
- NCT04656145
- Acronym / sponsor ID
- 20-01587
- Conditions
- Drain Site Complication
- Keywords
- Tegaderm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study team was not able to enroll eligible patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A paired study design will be used and subjects will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Gluconate Gel Dressing | Experimental | Device: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement DressingAll subjects are receiving two surgical drains during a single operative procedure. This arm will be randomized to receive the intervention. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement DressingOn 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. | Device | Chlorhexidine Gluconate Gel Dressing |
Primary outcome
Change in Erythema Measurement
Time frame: Day 0, up to Month 6
Drain site erythema will be measured with a ruler, in millimeters.
Number of participants in each category of skin induration (flat, soft, or firm)
Time frame: up to Month 6
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.
Change in distance between skin changes and normal looking skin
Time frame: Day 0, up to Month 6
Extent of skin changes is measured using a ruler, in millimeters, to calculate the distance between skin changes and normal looking skin.
Total amount of drainage from drain site
Time frame: Up to Month 6
Amount of drainage from drain site will be measured in cubic centimeters.
Number of participants who experience pain post-op
Time frame: Up to Month 6
5. Pain will be measured by asking patients if they experience pain (yes or no) when the clinician presses on the drain site.
Number of participants in each category of quality of drainage (serous, sanguineous, or purulent)
Time frame: Day 0, up to Month 6
Quality of drainage will be assessed by measuring thickness of drainage. Thickness of drainage will be measured as serous, sanguineous, or purulent.
4 secondary outcomes
Number of participants displaying signs of wound infection
Time frame: up to Month 6
Number of participants displaying sterility of seroma
Time frame: up to Month 6
Antibiotic prescription rate
Time frame: up to Month 6
Number of participants displaying presence of hematoma
Time frame: up to Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chiu, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing in people with Drain Site Complication, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Erythema Measurement (time frame: Day 0, up to Month 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.