BurnPhase 4NCT04516148
A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting
A Phase 4 study testing Cefazolin and Clindamycin in people with Burn and Surgery, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The purpose of this study if to evaluate the effectiveness of prophylactic antibiotics given during surgery in reducing the concentration of bacteria in a burn wound after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn, Surgery, Infection Wound
- What is being tested?
- Cefazolin and Clindamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 30 Oct 2020
- Phase
- Phase 4
- 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
- Subject age ≥ 18 years old at the time of consent
- Burn wound sustained less than 48 hours prior to the time of presentation to MedStar Washington Hospital Center
- Burn wounds solely due to a thermal mechanism
- Total body surface area burned ≤ 10%
- Anticipated to require a single grafting procedure
- Able to provide informed consent to participate
Who cannot join
- Positive pregnancy test in females of child bearing age
- Antibiotic administration within 30 days prior to admission
- Known / documented beta lactam allergy and clindamycin allergy
- Presence of burn wound cellulitis or infection pre-operatively
- Intraoperative discovery of infection
- Incarceration
- Presence of factors that may affect wound healing, per clinician judgment, such as chronic malnutrition and immunocompromised state
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study if to evaluate the effectiveness of prophylactic antibiotics given during surgery in reducing the concentration of bacteria in a burn wound after surgery.
Read the detailed description
This is a single-blind, randomized, controlled study to assess the effectiveness and safety of prophylactic perioperative administration of antibiotics for the reduction of bacterial concentration in burn wounds. Subjects who meet enrollment criteria will be randomized in a 1:1 ratio to receive either perioperative prophylaxis with intravenous antibiotics or institutional standard of care, consisting of no antibiotic therapy. This with be a single center study.
Following randomization, patients will receive their assigned treatment (antibiotics or standard of care) after induction of anesthesia, no more than one hour prior to incision.
Patients weighing 120 kg or less will receive 2 grams of intravenous cefazolin, with those weighing > 120 kg receiving 3 grams intravenous cefazolin. Re-dosing will occur every 4 hours that the patient remains in the operating room.
For patients with a documented beta-lactam allergy, Clindamycin 900 mg will be given intravenously with re-dosing every 6 hours that the patient remains in the operating room. Patients with allergies to both agents will be excluded from the study.
Biological samples will be obtained at three primary time-points: intraoperatively, at the time of the initial postoperative dressing take-down (within six hours), and at the time of a single follow up visit (10-28 days postoperatively).
- Conditions
- Burn, Surgery, Infection Wound
- Being tested
- Cefazolin, Clindamycin
- Keywords
- microbiome, perioperative, antibiotics, autograft, xenograft
- Medical subject headings
- Burns, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Dosing per hospital policy
ClindamycinDrug
Dosing per hospital policy
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Experimental | Patients randomized to the treatment arm of the study will have orders placed by a physician on the clinical team, with preparation and delivery of the antibiotics dose by the pharmacy following standard procedures. Antibiotic administration will occur after induction of anesthesia, with delivery by the Anesthesia staff no more than one hour prior to incision. Those with known allergy to beta-lactams will receive clindamycin instead of cefazolin. Receives: Drug: Cefazolin; Drug: Clindamycin |
| Standard of Care | No intervention | Patients randomized to the standard of care arm of the study will receive no perioperative antibiotic administration and will proceed with routine pre-operative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
burn wound bacterial concentration
The primary effectiveness endpoint is a statistically significant reduction in the burn wound bacterial concentration in wounds where patients received antibiotics. Samples (tissue swabs and punch biopsies) obtained intraoperatively following wound bed preparation will be compared to samples (tissue swabs and punch biopsies) obtained from the wound within six hours of initial postoperative dressing take-down.
Measured: 1-3 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start29 May 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516148
- Sponsor's protocol ID
- 2017-186
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting
- ClinicalTrials.gov ID
- NCT04516148
- Acronym / sponsor ID
- 2017-186
- Conditions
- Burn, Surgery, Infection Wound
- Keywords
- microbiome, perioperative, antibiotics, autograft, xenograft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 18 Aug 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.
The purpose of this study if to evaluate the effectiveness of prophylactic antibiotics given during surgery in reducing the concentration of bacteria in a burn wound after surgery.
Detailed description
This is a single-blind, randomized, controlled study to assess the effectiveness and safety of prophylactic perioperative administration of antibiotics for the reduction of bacterial concentration in burn wounds. Subjects who meet enrollment criteria will be randomized in a 1:1 ratio to receive either perioperative prophylaxis with intravenous antibiotics or institutional standard of care, consisting of no antibiotic therapy. This with be a single center study.
Following randomization, patients will receive their assigned treatment (antibiotics or standard of care) after induction of anesthesia, no more than one hour prior to incision.
Patients weighing 120 kg or less will receive 2 grams of intravenous cefazolin, with those weighing > 120 kg receiving 3 grams intravenous cefazolin. Re-dosing will occur every 4 hours that the patient remains in the operating room.
For patients with a documented beta-lactam allergy, Clindamycin 900 mg will be given intravenously with re-dosing every 6 hours that the patient remains in the operating room. Patients with allergies to both agents will be excluded from the study.
Biological samples will be obtained at three primary time-points: intraoperatively, at the time of the initial postoperative dressing take-down (within six hours), and at the time of a single follow up visit (10-28 days postoperatively).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Experimental | Drug: Cefazolin, Drug: ClindamycinPatients randomized to the treatment arm of the study will have orders placed by a physician on the clinical team, with preparation and delivery of the antibiotics dose by the pharmacy following standard procedures. Antibiotic administration will occur after induction of anesthesia, with delivery by the Anesthesia staff no more than one hour prior to incision. Those with known allergy to beta-lactams will receive clindamycin instead of cefazolin. |
| Standard of Care | No intervention | –Patients randomized to the standard of care arm of the study will receive no perioperative antibiotic administration and will proceed with routine pre-operative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject age ≥ 18 years old at the time of consent
- Burn wound sustained less than 48 hours prior to the time of presentation to MedStar Washington Hospital Center
- Burn wounds solely due to a thermal mechanism
- Total body surface area burned ≤ 10%
- Anticipated to require a single grafting procedure
Key exclusion criteria (7 listed)
- Positive pregnancy test in females of child bearing age
- Antibiotic administration within 30 days prior to admission
- Known / documented beta lactam allergy and clindamycin allergy
- Presence of burn wound cellulitis or infection pre-operatively
- Intraoperative discovery of infection
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 |
|---|---|---|
| CefazolinDosing per hospital policy | Drug | Antibiotics |
| ClindamycinDosing per hospital policy | Drug | Antibiotics |
Primary outcome
burn wound bacterial concentration
Time frame: 1-3 days from surgery
The primary effectiveness endpoint is a statistically significant reduction in the burn wound bacterial concentration in wounds where patients received antibiotics. Samples (tissue swabs and punch biopsies) obtained intraoperatively following wound bed preparation will be compared to samples (tissue swabs and punch biopsies) obtained from the wound within six hours of initial postoperative dressing take-down.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin and Clindamycin in people with Burn and Surgery, run by Medstar Health Research Institute 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 26 Aug 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
burn wound bacterial concentration (time frame: 1-3 days from surgery). 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 26 Aug 2022.