The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair
| Status: | Withdrawn |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | Any - 60 |
| Updated: | 12/23/2017 |
| Start Date: | April 2016 |
| End Date: | March 2018 |
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.
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.
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.
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.
Inclusion Criteria:
1. Ages 1 month to 60 years
2. Subjects undergoing independently scheduled elective Cleft Palate of VPI repair
3. Do not meet any exclusion criteria
Exclusion Criteria:
1. Any repeat repair
2. Symptoms of upper respiratory infection
3. Immunosuppressed
4. Allergy to Amoxicillin or any other Penicillins
5. Antibiotic usage <2weeks prior to scheduled surgery other than immediate pre-operative
antibiotics
6. Inability to follow up
We found this trial at
2
sites
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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