Cleft PalateCleft PalateNCT02688634
The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair
An observational study of Cleft Palate, run by University of Florida at 2 sites in United States.
Trial summary
Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis… Read more about this study
- Who is it for?
- Ages 1 month to 60 years
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to Mar 2018
- Phase
- Observational
- 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 1 month to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects undergoing independently scheduled elective Cleft Palate of VPI repair at an area hospital
Who may be able to join
- Ages 1 month to 60 years
- Subjects undergoing independently scheduled elective Cleft Palate of VPI repair
- Do not meet any exclusion criteria
Who cannot join
- Any repeat repair
- Symptoms of upper respiratory infection
- Immunosuppressed
- Allergy to Amoxicillin or any other Penicillins
- Antibiotic usage <2weeks prior to scheduled surgery other than immediate pre-operative antibiotics
- Inability to follow up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health at Shands Hospital
Gainesville, Florida, 32610
University of Florida
Gainesville, Florida, 32610
About this study
Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis, dehiscence, or fistula formation. The surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological organisms, indeed the human bite is one of the more clinically and microbiologically significant injuries to treat. This research study is to elucidate the role, if any, that prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and VPI repair and potentially establish a new paradigm of care.
Read the detailed description
This will be a randomized prospective research study. Participants who will undergo an elective CP or VPI surgery will be randomized to receive either 1) antibiotics or 2) nothing postoperatively. All participants will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.
- Conditions
- Cleft Palate
- Being tested
- Amoxicillin
- Keywords
- Cleft Palate Surgery, Antibiotic treatment
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Antibiotics
Amoxicillin will be given as: 7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Participants in this group are randomize to receive post-operative antibiotic of Amoxicillin x7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care. Receives: Drug: Amoxicillin | |
| Non-Treatment | Participants in this group will be randomize to no post-operative antibiotic. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rates between the groups
Analysis of infection is based on a 7 point scale to allow for broadened data but can be evaluated in a binary fashion for ≥ 4 indicating infection and <4 as no infection. A χ2 test and Fisher's exact test for p<0.05 will be used to determine significance of the difference in complication (cellulitis and upper respiratory infection) rates between the two groups.
Measured: 30 days
Dehiscence and fistula formation between the groups
Both dehiscence and fistula formation will also be recorded as a binary present/not present data point to determine the significance of the difference in complication rates between the groups.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Lentz, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688634
- Sponsor's protocol ID
- IRB201500667
- Acronym
- Cleft Palate
- Status last verified
- Dec 2017
- First submitted
- 17 Feb 2016
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair
- ClinicalTrials.gov ID
- NCT02688634
- Acronym / sponsor ID
- Cleft Palate / IRB201500667
- Conditions
- Cleft Palate
- Keywords
- Cleft Palate Surgery, Antibiotic treatment
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 23 Feb 2016 (estimated)
- 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.
Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis, dehiscence, or fistula formation. The surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological organisms, indeed the human bite is one of the more clinically and microbiologically significant injuries to treat. This research study is to elucidate the role, if any, that prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and VPI repair and potentially establish a new paradigm of care.
Detailed description
This will be a randomized prospective research study. Participants who will undergo an elective CP or VPI surgery will be randomized to receive either 1) antibiotics or 2) nothing postoperatively. All participants will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: AmoxicillinParticipants in this group are randomize to receive post-operative antibiotic of Amoxicillin x7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care. |
| Non-Treatment | – | –Participants in this group will be randomize to no post-operative antibiotic. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care. |
Who may qualify
- Ages
- 1 month to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects undergoing independently scheduled elective Cleft Palate of VPI repair at an area hospital
Key inclusion criteria (3 listed)
- Ages 1 month to 60 years
- Subjects undergoing independently scheduled elective Cleft Palate of VPI repair
- Do not meet any exclusion criteria
Key exclusion criteria (6 listed)
- Any repeat repair
- Symptoms of upper respiratory infection
- Immunosuppressed
- Allergy to Amoxicillin or any other Penicillins
- Antibiotic usage <2weeks prior to scheduled surgery other than immediate pre-operative antibiotics
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 |
|---|---|---|
| AmoxicillinAlso: AntibioticsAmoxicillin will be given as: 7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period. | Drug | Treatment |
Primary outcome
Infection rates between the groups
Time frame: 30 days
Analysis of infection is based on a 7 point scale to allow for broadened data but can be evaluated in a binary fashion for ≥ 4 indicating infection and <4 as no infection. A χ2 test and Fisher's exact test for p<0.05 will be used to determine significance of the difference in complication (cellulitis and upper respiratory infection) rates between the two groups.
Dehiscence and fistula formation between the groups
Time frame: 30 days
Both dehiscence and fistula formation will also be recorded as a binary present/not present data point to determine the significance of the difference in complication rates between the groups.
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 21 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Cleft Palate
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Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
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Furlow With Buccinator and Fistula Formation
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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.
Ashley Lentz, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate, run by University of Florida at 2 sites 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 3 inclusion and 6 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 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Infection rates between the groups (time frame: 30 days). The study lists 2 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 21 Dec 2017.