High Dissolving Food for Facial Reconstruction

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Tube feeding, Speech restrictions, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special kind of food designed to aid recovery in children after certain facial surgeries. The study compares two groups: one receives this new high-dissolving transitional food post-operation, while the other follows the usual recovery routine. It includes children aged 6 months to 18 years who eat by mouth and are scheduled for specific facial surgeries, such as cleft palate repair. Participants must also attend all necessary pre- and post-surgery visits. As an unphased trial, this study provides a unique opportunity to contribute to innovative recovery methods for children.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this high dissolving transitional food is safe for post-operative use in craniofacial procedures?

Research has shown that foods dissolving quickly, like applesauce and Crispy Melt, are generally safe to eat. These foods break down easily in the mouth with saliva and warmth, reducing the risk of swallowing issues.

One study found that oral dissolving films, similar to these foods, are also safe and easy to consume. They dissolve quickly, ensuring safe and easy eating.

Although specific information on side effects may be lacking, these foods are designed to be gentle on the stomach, making problems unlikely. If concerns arise, consulting a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the high dissolving transitional food for facial reconstruction because it offers a unique approach to post-surgery recovery. Unlike traditional dietary adjustments or supplements that can be difficult to consume after facial surgery, this innovative food product dissolves easily, making it much simpler for patients to ingest and absorb nutrients. This could potentially speed up recovery time and improve overall patient comfort during the healing process. By providing essential nutrition in an easily digestible form, this treatment aims to enhance outcomes for patients undergoing facial reconstruction.

What evidence suggests that high dissolving transitional food is effective for post-operative recovery in craniofacial procedures?

Research has shown that oral dissolving films, similar to the special food used in this trial's intervention group, provide a safe and easy method for delivering nutrients and medications. These films dissolve quickly in the mouth, aiding patients who struggle to swallow after facial surgery. Advances in this technology simplify treatment adherence, as the films are easy to use and transport. Although specific data on this special food for facial surgery remains limited, the mechanism of these films suggests they could support healing and recovery by ensuring patients receive necessary nutrition. ^{6 7 8 9 10}

Who Is on the Research Team?

Roberto Flores, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients undergoing craniofacial procedures. Participants will be those who meet specific criteria to ensure they are suitable for the study, but detailed inclusion and exclusion criteria have not been provided.

Inclusion Criteria

I am scheduled for surgery related to my cleft/craniofacial condition this year.

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 with diagnosed allergies to ingredients in Savorease Therapeutic Foods

Patients/caregivers unable to participate in pre- and post-operative protocoled visits

Patients with PO recommendations preventing consumption of Level 4 IDDSI foods

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants are assessed at the pre-operative visit, including wound examination and weight measurement

Baseline

1 visit (in-person)

Post-operative

Participants receive either novel high dissolving transitional foods or standard care, with follow-up visits to assess wound issues and weight

3 weeks

2 visits (in-person) at 1 and 3 weeks post-op

Follow-up

Participants are monitored for safety and effectiveness, including 30-day readmission rate

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Dissolving Transitional Food

Trial Overview The study is testing high dissolving transitional foods in patients after facial reconstruction surgery. One group receives these novel foods post-operation, while the other follows standard care without them. Their recovery is compared at 1 and 3 weeks post-surgery.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients randomized to the intervention group will receive a high dissolving transitional food product.

Group II: Standard of Care Group Active Control 1 Intervention

Patients randomized to the standard of care group will not receive a high dissolving transitional food product.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836581/

Hyaluronidase for Dermal Filler Complications - PubMed Central Hyaluronidase (Hyal) can reverse complications of hyaluronic acid (HA) fillers, which has contributed substantially to the popularity of such procedures.

2. researchgate.net researchgate.net/publication/387897959_Advances_in_oral_dissolving_film_research_in_the_food_field

(PDF) Advances in oral dissolving film research in the food ... Oral dissolving film (ODF) emerges as a novel active substance delivery system, offering portability, safety, and com‑. pliance.

3. ajo.com ajo.com/article/S0002-9394(25)00274-0/fulltext

TFOS DEWS III: Management and Therapy Diet also plays a role in DED severity. Diets rich in omega-3 fatty acids, found in fish and flaxseeds, can improve tear quality and reduce inflammation.

4. nature.com nature.com/articles/s41467-025-65498-1

In situ gut microbiota editing: enhancing therapeutic ... Gut microbiota editing represents a promising therapeutic strategy for dysbiosis-associated diseases. Bacteriophages (phages), with their ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0266435623001146

Systematic review Safety and efficacy of adjunctive therapy ... Mild postoperative paraesthesia was diagnosed in 25% (n = 2) of patients treated with CS. In 50% (n = 1) it was transient with clinical recovery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12573265/

Transitional Foods and their Effects on Swallowing Safety ... Patients were instructed to consume applesauce and Crispy Melt in one bite and swallow as they normally would. Patients were instructed to take a single bite ...

7. swallowstudy.com swallowstudy.com/cotton-candy-therapy-transitional-foods-dysphagia-treatment/

Cotton Candy Therapy? Transitional Foods & Dysphagia ... According to IDDSI, transitional foods start as a solid & dissolve in the mouth w/ moisture & heat. This is a 2-part blog all about these ...

8. fppn.biomedcentral.com fppn.biomedcentral.com/articles/10.1186/s43014-024-00285-x

Advances in oral dissolving film research in the food field In summary, ODFs offer significant advantages including rapid absorption, high safety compliance, increased bioavailability, and avoidance of ...

9. ec.europa.eu ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_175.pdf

SCCS/1545/15 Revision of 29 September 2015 SCCS. The Committee shall provide opinions on questions concerning all types of health and safety risks (notably chemical, biological, ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2213453022001513

Development of hyaluronic acid-based edible film for ... All of the HA films showed safety against microorganism during 28 storage day at 40 °C with 60 % humidity. The optimum site for film attachment in mouth was the ...