Clinical Trial: The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair

Brief 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, 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 Summary: 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.
Sponsor: University of Florida

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Florida

Dates:
Date Received: February 17, 2016
Date Started: April 2016
Date Completion: March 2018
Last Updated: December 14, 2016
Last Verified: December 2016