Wound Infection Post-TraumaticNCT03815500
Patient Education at Dismissal After Surgical Procedure
A study testing Enhanced Education in people with Wound Infection Post-Traumatic and Wound Infection, run by Mayo Clinic.
Trial summary
Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection Post-Traumatic, Wound Infection, Wound Complication
- What is being tested?
- Enhanced Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients on the general surgery service with open wounds requiring packing
Who cannot join
- Patients with wound vacs
- Patients receiving exclusively professional wound care or home health services
About this study
Official title: Patient Education at Dismissal After Surgical Procedure: Clinical Outcome Implications and Improvement Strategies
Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.
Read the detailed description
The investigators seek to address the specific educational needs of patients and caregivers with low-literacy, dyslexia and related learning disabilities in the context of properly performing wound care for patients with surgical wounds. Specific aims include both improving care by decreasing wound complications and improving patient satisfaction by using techniques designed for this population. Objectives include utilizing surveys to determine the incidence of dyslexia among the patients' and caregivers' within the general surgery service as well as the perception of our current educational offerings, to design a new dismissal package with enhanced educational offerings, to re-measure this effect on the patient experience with survey data, and to compare wound infection rates before and after implementing the new curriculum. Dyslexia and associated learning disabilities are common and likely impact the health literacy among this population due to the ubiquitous literacy-based documentation of hospital course and dismissal instructions. Adults with dyslexia may be reluctant to disclose any inability to understand written instructions. There is currently no mechanism within the dismissal system to specifically identify and address the unique needs of this population. The impact on clinical outcomes of proper wound packing is substantial, and if performed incorrectly can lead to slow wound healing and infections that often require readmission, multiple courses of antibiotics, and reoperation. In severe cases, improper wound care can lead to severe infection, sepsis, and death. By enhancing the educational offerings of proper wound care to this population, the investigators hope to reduce these complications.
- Conditions
- Wound Infection Post-Traumatic, Wound Infection, Wound Complication, Wound Breakdown, Wound Open
- Being tested
- Enhanced Education
- Medical subject headings
- Wound Infection, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Enhanced Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Patient satisfaction with wound education
Survey of patients' wound education experiences should indicate that they are being offered curriculum suitable for learners with low literacy, dyslexia and associated learning disorders. We will utilize a scale of "Definitely satisfied, somewhat satisfied, somewhat dissatisfied, definitely dissatisfied" as our measure.
Measured: 6 months
shorter time to wound healing
After implementation of new curriculum, it is anticipated that wound complication rates and time to wound healing would decrease. We will calculate the "time" based on the date of wound creation to their final clinic appointment indicated the wound is satisfactorily healed with "days" as our unit of measure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jul 2019
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: PI no longer with the organization, no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin D Zielinski, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815500
- Sponsor's protocol ID
- 18-008124
- Status last verified
- Aug 2022
- First submitted
- 8 Jan 2019
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education at Dismissal After Surgical Procedure: Clinical Outcome Implications and Improvement Strategies
- ClinicalTrials.gov ID
- NCT03815500
- Acronym / sponsor ID
- 18-008124
- Conditions
- Wound Infection Post-Traumatic, Wound Infection, Wound Complication, Wound Breakdown, Wound Open
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI no longer with the organization, no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.
Detailed description
The investigators seek to address the specific educational needs of patients and caregivers with low-literacy, dyslexia and related learning disabilities in the context of properly performing wound care for patients with surgical wounds. Specific aims include both improving care by decreasing wound complications and improving patient satisfaction by using techniques designed for this population. Objectives include utilizing surveys to determine the incidence of dyslexia among the patients' and caregivers' within the general surgery service as well as the perception of our current educational offerings, to design a new dismissal package with enhanced educational offerings, to re-measure this effect on the patient experience with survey data, and to compare wound infection rates before and after implementing the new curriculum. Dyslexia and associated learning disabilities are common and likely impact the health literacy among this population due to the ubiquitous literacy-based documentation of hospital course and dismissal instructions. Adults with dyslexia may be reluctant to disclose any inability to understand written instructions. There is currently no mechanism within the dismissal system to specifically identify and address the unique needs of this population. The impact on clinical outcomes of proper wound packing is substantial, and if performed incorrectly can lead to slow wound healing and infections that often require readmission, multiple courses of antibiotics, and reoperation. In severe cases, improper wound care can lead to severe infection, sepsis, and death. By enhancing the educational offerings of proper wound care to this population, the investigators hope to reduce these complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with open surgical wounds | Experimental | Behavioral: Enhanced EducationPatients with open surgical wounds will undergo enhanced packing education with curriculum designed for learners with low literacy, dyslexia or associated learning disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients on the general surgery service with open wounds requiring packing
Key exclusion criteria (2 listed)
- Patients with wound vacs
- Patients receiving exclusively professional wound care or home health services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced EducationEnhanced 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. | Behavioural | Patients with open surgical wounds |
Primary outcome
Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders
Time frame: 6 months
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.
2 secondary outcomes
Patient satisfaction with wound education
Time frame: 6 months
shorter time to wound healing
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin D Zielinski principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Education in people with Wound Infection Post-Traumatic and Wound Infection, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.