Cleft Palates Clinical Trial
Official title:
Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates
The primary objective of this study is to determine the efficacy of administering a single
dose of preoperative antibiotics to prevent complications in patients undergoing primary
closure of a cleft secondary palate. Secondary objective of this study is to evaluate the
effects of preoperative antibiotics administered on post operative outcome following primary
closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic
antibiotics in cleft surgery to
- decrease the incidence of surgical sight infections
- speed the progression of postoperative healing
- improve the final quality of wound healing achieved
- decrease the rate of palatal fistula formation
During the initial clinical visit, the clinical diagnosis of a cleft secondary palate or
submucous cleft will be made. Other associated clinical findings such as unilateral/bilateral
cleft lip, unilateral/bilateral cleft primary palate, Veau cleft palate classification, and
associated syndromic diagnosis will be recorded. The severity of the cleft palate will be
documented by measuring the width of the cleft and the hard-soft palate juncture. The
patients will proceed through the standardized cleft treatment protocol as mandated by their
specific anatomic findings. These include possible naso-alveolar molding, lip-adhesion
procedures, and cleft lip repair procedures. The patients will be followed regularly in
clinic and will undergo a palatoplasty procedure to repair their cleft secondary palate when
clinically indicated, typically between the age of 9 and 14 months. Patients who present for
treatment late will be operated on when clinically appropriate, as determined by the plastic
surgeon. A Furlow palatoplasty procedure is the typical palatoplasty procedure performed by
the primary investigator, but other procedures such a Von Langenbeck pushback palatoplasty
may be performed as dictated by the clinical scenario.
Subjects will be randomized via aid from statisticians in the Clinical and Translational
Science Institute (CTSI) here at the University of Pittsburgh. This will enable the research
pharmacist at Children's Hospital of Pittsburgh, to send either the antibiotic or the saline
placebo to the operating room in a blinded manner. All subjects enrolled in the study will
receive a single dose of antibiotic or saline solution (placebo control) intravenously, as
the IV will already be in place as standard of card for surgery. Subjects will receive the
antibiotic or the saline placebo 30 minutes prior to the initial incision in their
palatoplasty procedure. The FDA approved antibiotic used for this study is Unasyn. Unasyn is
a first-line measure, used by ENT surgeons at Children's Hospital of Pittsburgh for
antibiotic treatment of virtually all ear, nose and throat infections. The use of Unasyn for
this study is off-label as with the majority of antibiotics used with children. Subjects will
receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm. This
constitutes the focus of the study, and is the only variation from standard treatment.
Patients will be admitted to the hospital, and will be discharged home when they are in no
respiratory distress, have adequate pain control, and are able to tolerate adequate PO
intake. This is generally on post-operative day 2. All patients will be prescribed pain
medications. Parents will be provided with, and counseled how to properly use arm splints for
14 days postoperatively. They will also be taught how to feed the child with syringe feeds.
These measures prevent the child from traumatizing the suture lines with bottles, hands and
foreign bodies.
Screening procedures will consist of a medical history and physical examination by a
Pediatric Plastic Surgeon to determine what type of cleft palate repair is necessary. This is
the same standard exam and medical/surgical work-up that any patient would receive if they
were treated by the Cleft-Craniofacial Clinic in Children's Hospital of Pittsburgh of UPMC
and not enrolled in this study. This aspect of care will not vary from routine treatment. All
patients will be seen in weekly postoperative follow-up in the Cleft-Craniofacial Center.
Documentation of these postoperative visits will include notation of signs of surgical sight
infections, such as continued fevers, erythema, swelling, discharge, dehiscence, pain, and
the presence of nonviable tissue. The progression of wound healing will be quantified on a
scale of 1 to 4. Wounds will be classified as Stage 1 healing when there is complete union of
the mucosa, and no irregularities or separation. Stage 2 healing will be documented for
wounds with minor incisional irregularities or incomplete healing. Stage 3 healing will be
documented when the wound exhibits worrisome mucosal viability, partial dehiscence of the
oral mucosal closure, erythema, purulent drainage, or exposure of the alloderm patch. Stage 4
healing will include patients with a palatal fistula. Any patients with clinical signs and
symptoms of thrush, a fungal infection of the mouth and esophagus, will have cultures of the
lesions sent to confirm the diagnosis. These patients will be immediately started on a seven
day course of oral fluconazole, with an initial dose of 6mg/kg, followed by daily dose of
3mg/kg, as recommended by Dr. Andrew Nowalk, MD. Patients will be seen in clinic weekly until
they have reached stage 1 healing, or until the presence of a palatal fistula is documented.
We anticipate a minimum of less than 2 months to a maximum of 1 year for follow-up will be
necessary to document either stage 1 healing or the presence of a palatal fistula in nearly
all cases. The primary endpoints measured will be 1) the incidence of surgical sight
infections, 2) the incidence of palatal fistula 3) the average time needed to achieve stage 1
healing, 4) the incidence of cases with healing delayed more than one standard deviation from
the average, 5) the incidence of thrush, a fungal infection of the mouth and esophagus, and
6) the incidence of allergic/drug reactions to the study drug. Surveillance for other factors
such as hospital length of stay, postoperative bleeding events, postoperative respiratory
distress, and diagnosis of a sepsis will be recorded as secondary endpoints.
Data collection will include patient characteristics such as, but not limited to, Veau cleft
classification, width of the cleft defect, presence of associated cleft lip or primary
palate, presence of syndromic diagnosis, and use of alloderm for repair augmentation, and the
administration of intraoperative steroids. The two study groups will be compared on the basis
of these characteristics to determine if statistically significant differences exist between
the two groups. Endpoint data will be collected as discussed above, and the outcomes for the
placebo and antibiotic group will be compared.
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