Use of a Medical Food in Adults Undergoing Surgery | NCT04041908

Studies
Use of a Medical Food in Adults Undergoing Surgery

NCT04041908

Sponsor

Abbott Nutrition

Status

Terminated

Last Update Posted

May 1, 2020Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Compliance, Patient

Interventions

Experimental Product

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment

Expanded Access Info

Start Date

Mar 13, 2020Actual

Primary Completion Date

Apr 10, 2020Actual

Completion Date

Apr 10, 2020Actual

First Submitted Date

Jul 30, 2019

First Submission Date that Met QC Criteria

Jul 31, 2019

First Posted Date

Aug 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2020

Last Update Posted Date

May 1, 2020Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
Experimental Product	Experimental	Drink mix powder	Other: Experimental Product

Name	Type	Description	Arm Group Labels	Other Names
Experimental Product	Other	2 sachets per day	Experimental Product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Product Compliance	Percent of required study product intake from subject completed intake questionnaire	Study Day 1 to Study Day 30

Secondary Outcomes

Measure	Description	Time Frame
Investigator Wound Assessment	Percent of patients with complete wound healing based on physician assessment	Study Day 1 to Study Day 30
Participant Wound Assessment Questionnaire	Participant completed 4 questions related to wound healing experience; 3 Likert-type questions scaled from 1-10 in negative direction; 1 dichotomous scale question

Other Outcomes

Measure	Description	Time Frame
Product Evaluation Questionnaire	Participant completed questionnaire; 4 Likert-type questions scaled from 1 - 9 in the negative direction; 2 Likert-type questions scaled from 1 - 5 in the negative direction	Study Day 30/Exit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is scheduled to have non-melanoma skin cancer on either the head, leg, trunk and arm removed with final wound size of 1.0 to < 5.0 cm in diameter or with 1.0 < 5.0 cm long axis if not circular that will be healed by secondary intent
Participant has an acceptable state of health and nutrition
Participant agrees not to begin taking any new medications, dietary supplements, or alternative therapies during the study period
Participant is interested in participating in the study, willing to comply with the study protocol, and willing to consume two servings of drink mix per day according to the protocol
Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability (HIPAA) authorization prior to any study participation

Exclusion Criteria:

Participant has a disease or condition that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the participant with study visits/procedures
Participant has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
Participant has known immunosuppression
Participant has platelet or coagulation disorders
Therapy with another investigational agent within 30 days of Visit 1 that has not been approved
Systemic infection at the time of enrollment in the study
Currently receiving or have received recombinant human platelet-derived growth factor or similar therapies, or other bioengineered tissue therapy within the previous 4 weeks
Participant has an allergy or intolerance to any ingredient in the study product
Participant is taking nutritional supplement(s)/capsules/formulas for wound healing and is unwilling to discontinue therapy for the duration of the study
Participation in another clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior