NCT03815500

Brief Summary

Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

3.9 years

First QC Date

January 8, 2019

Last Update Submit

August 12, 2022

Conditions

Wound Infection Post-TraumaticWound InfectionWound ComplicationWound BreakdownWound Open

Outcome Measures

Primary Outcomes (1)

  • Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders

    Nursing surveys answering the question, "Have you been trained to teach wound care to patients with dyslexia or learning disabilities?" Were answered "No," by 43/46 (93%) respondents. We seek to have a 90% rate of affirmative ("Yes") answers to this survey after implementation of our curriculum.

    6 months

Secondary Outcomes (2)

  • Patient satisfaction with wound education

    6 months

  • shorter time to wound healing

    1 year

Study Arms (1)

Patients with open surgical wounds

EXPERIMENTAL

Patients with open surgical wounds will undergo enhanced packing education with curriculum designed for learners with low literacy, dyslexia or associated learning disorders.

Behavioral: Enhanced Education

Interventions

Enhanced EducationBEHAVIORAL

Enhanced educational curriculum will involve learning modalities including 3D modeling, video, and visual-aid enhanced text for references to improve caregiver and patient understanding of wound packing techniques.

Patients with open surgical wounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients on the general surgery service with open wounds requiring packing

You may not qualify if:

  • Patients with wound vacs
  • Patients receiving exclusively professional wound care or home health services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Wound InfectionSurgical Wound Dehiscence

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin D Zielinski

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 24, 2019

Study Start

July 1, 2019

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08