Trial Outcomes & Findings for Preventing Complications in Cleft Palate Repair With Antibiotics (NCT NCT00760006)

Last Updated: 2018-02-01

Results Overview

Primary outcomes of fistula or delayed wound healing following palatoplasty were measured in two groups of patients. This outcome measure addresses both objectives noted in the summary of the study description.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

224 participants

Primary outcome timeframe

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.

Results posted on

2018-02-01

Participant Flow

Protocol exclusion criteria includes children already receiving antibiotics at the time of their surgery, and will be evaluated distinctly, but will not be included in the antibiotic or placebo groups. Therefore, only participants receiving preoperative antibiotics are considered for our outcome measure.

Participant milestones

Participant milestones
Measure	Unasyn Antibiotic Arm Active Comparator: Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. 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 care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation. Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm	Saline Placebo Arm Other Names: * Salt solution * Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm
Overall Study STARTED	86	138
Overall Study COMPLETED	86	138
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unasyn Antibiotic Arm n=86 Participants Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. 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 care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation. Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm	Saline Placebo Arm n=138 Participants Other Names: * Salt solution * Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm	Total n=224 Participants Total of all reporting groups
Age, Categorical <=18 years	86 Participants n=86 Participants	138 Participants n=138 Participants	224 Participants n=224 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=86 Participants	0 Participants n=138 Participants	0 Participants n=224 Participants
Age, Categorical >=65 years	0 Participants n=86 Participants	0 Participants n=138 Participants	0 Participants n=224 Participants
Sex: Female, Male Female	39 Participants n=86 Participants	62 Participants n=138 Participants	101 Participants n=224 Participants
Sex: Female, Male Male	47 Participants n=86 Participants	76 Participants n=138 Participants	123 Participants n=224 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	86 Participants n=86 Participants	138 Participants n=138 Participants	224 Participants n=224 Participants

PRIMARY outcome

Timeframe: 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.

Population: Only participants receiving preoperative antibiotics are considered for this outcome measure. Please refer to the exclusion criteria listed in the initial protocol -- "Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or placebo groups.

Outcome measures

Outcome measures
Measure	Unasyn Antibiotic Arm n=86 Participants Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. 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 care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation. Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm	Saline Placebo Arm n=138 Participants Other Names: * Salt solution * Saline Solution Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm
Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty Fistula	3 Participants	2 Participants
Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty Delayed Wound Healing	18 Participants	21 Participants

Adverse Events

Unasyn Antibiotic Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Placebo Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph E. Losee

Chilsren's Hospital of Pittsburgh of UPMC

Phone: 412-692-6203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place