Craniofacial Surgery
Conditions
Brief summary
This is a prospective comparative study, where patients who meet inclusion criteria undergoing a craniofacial procedure will either be provided with novel high dissolving transitional foods for use in the post-operative period (Intervention Group) or will not be provided the food and will proceed as per current standard of care (Standard of Care Group). Both groups will be followed pre-operatively at time of pre-operative visit, and will be followed in the post-operative period, with two visits at 1 and 3 weeks post-operatively, respectively.
Interventions
DIETARY_SUPPLEMENTHigh Dissolving Transitional Food
Transitional foods are solid foods that rapidly change texture in the presence of moisture (e.g., water or saliva) or temperature change. Duration of consumption of the investigational agent will include the time of the surgery until the second post-operative evaluation. This is estimated to be approximately 1-2 months in total.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients ages 0 years, 6 months to 18 years of age * Patients with a diagnosed cleft/craniofacial condition undergoing one of the following cleft/craniofacial related surgeries in the upcoming calendar year (a-c): 1. Cleft Palate Repair (Palatoplasty) 2. Alveolar Bone Graft Surgery 3. Velopharyngeal Insufficiency Surgery * Patients who eat fully by mouth (PO) * Patients who adhered to scheduling protocols and attended all necessary pre- and post-operative visits
Exclusion criteria
* Patients under the age of 6 months or over the age of 18 * Patients who utilize an NG-tube or G-tube for primary means of nutrition/hydration * Patients who have PO recommendations from a licensed Speech-Language Pathologist that prevents their ability to consume Level 4 IDDSI (pureed) foods, including patients who are NPO. * Patients with any diagnosed allergies to the ingredients listed on the Savorease Therapeutic Foods ingredient labels * Patients/caregivers who are not able to participate in pre- and post-operative protocoled visits for any reason * Patients/caregivers who are not able to respond to written questions presented in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver-Reported Rating of Feeding Experience | Week 1 Post-Operation (Post-Op) | Caregivers of participants will complete short survey to assess patient's feeding-related quality of life (QOL) related to the post-operative period. The survey comprises 10 items; each item utilizes a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). The total score is the sum of responses and ranges from 0-40; lower scores indicate greater feeding-related QOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Wound Issues at Pre-Op Visit | Baseline (Pre-Op Visit) | Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications. |
| Number of Participants with Wound Issues at Week 1 Post-Op | Week 1 Post-Op | Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications. |
| Number of Participants with Wound Issues at Week 3 Post-Op | Week 3 Post-Op | Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications. |
| 30-Day Readmission Rate | Day 30 Post-Op | Percentage of participants who are readmitted to the hospital within 30 days post-operation. |
| Average Participant Weight at Pre-Op Visit | Baseline (Pre-Op Visit) | Participant weight is measured in pounds (lbs). |
| Average Participant Weight at Week 1 Post-Op | Week 1 Post-Op | Participant weight is measured in pounds (lbs). |
| Average Participant Weight at Week 3 Post-Op | Week 3 Post-Op | Participant weight is measured in pounds (lbs). |
| Number of Participants who Self-Report Use of Pain Medicine at Pre-Op Visit | Baseline (Pre-Op Visit) | — |
| Number of Participants who Self-Reported Use of Pain Medicine at Week 1 Post-Op | Week 1 Post-Op | — |
| Number of Participants who Self-Reported Use of Pain Medicine at Week 3 Post-Op | Week 3 Post-Op | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRoberto Flores, MD
NYU Langone Health
Outcome results
None listed