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Preventing Complications in Cleft Palate Repair With Antibiotics

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ClinicalTrials.gov Identifier: NCT00760006
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Losee, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Cleft Palates
Interventions Drug: Unasyn
Other: saline solution
Enrollment 224
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Unasyn Antibiotic Arm Saline Placebo Arm
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 86 138
Completed 86 138
Not Completed 0 0
Arm/Group Title Unasyn Antibiotic Arm Saline Placebo Arm Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 86 138 224
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 138 participants 224 participants
<=18 years
86
 100.0%
138
 100.0%
224
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 138 participants 224 participants
Female
39
  45.3%
62
  44.9%
101
  45.1%
Male
47
  54.7%
76
  55.1%
123
  54.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 86 participants 138 participants 224 participants
86
 100.0%
138
 100.0%
224
 100.0%
1.Primary Outcome
Title Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unasyn Antibiotic Arm Saline Placebo Arm
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 86 138
Measure Type: Count of Participants
Unit of Measure: Participants
Fistula
3
   3.5%
2
   1.4%
Delayed Wound Healing
18
  20.9%
21
  15.2%
Time Frame [Not Specified]
Adverse Event Reporting Description As noted in the protocol exclusion criteria, children already receiving antibiotics at the time of their surgery were evaluated distinctly, though they were not included in the antibiotic or placebo groups. Only participants receiving preoperative antibiotics are considered for outcome measure and adverse events.
 
Arm/Group Title Unasyn Antibiotic Arm Saline Placebo Arm
Hide Arm/Group Description

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

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

All-Cause Mortality
Unasyn Antibiotic Arm Saline Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/138 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Unasyn Antibiotic Arm Saline Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/138 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Unasyn Antibiotic Arm Saline Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/138 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Joseph E. Losee
Organization: Chilsren's Hospital of Pittsburgh of UPMC
Phone: 412-692-6203
EMail: joseph.losee@chp.edu
Layout table for additonal information
Responsible Party: Joseph Losee, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00760006     History of Changes
Other Study ID Numbers: 07090352
First Submitted: September 24, 2008
First Posted: September 25, 2008
Results First Submitted: October 19, 2017
Results First Posted: February 1, 2018
Last Update Posted: February 1, 2018