Congenital MicrotiaNCT06569927
Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
A study testing Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model. in people with Congenital Microtia, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Aims and objectives: To evaluate the clinical application and effectiveness of a perioperative position management program constructed using the ADDIE model for patients with congenital microtia. Read more about this study
- Who is it for?
- Ages 6 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Microtia
- What is being tested?
- Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 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 6 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of congenital microtia according to the "Chinese Plastic Surgery" criteria, and undergoing ear reconstruction.
- No other severe comorbidities.
Who cannot join
- Abnormal coagulation function.
- Presence of eczema or infection on the affected side.
- Severe cognitive impairment or mental illness.
- Patient or family disagrees with the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Eye & ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Aims and objectives: To evaluate the clinical application and effectiveness of a perioperative position management program constructed using the ADDIE model for patients with congenital microtia.
Background: The primary challenge in auricular reconstruction is the fragility of the reconstructed ear structure, necessitating strict avoidance of postoperative pressure to ensure the surgery's effect. Clinically, this has been found to cause anxiety in patients and their families. Some patients maintain a fixed position to avoid pressure on the reconstructed ear, which may lead to restricted neck movement and a high risk of pressure-related injuries. Therefore, a systematic perioperative position management program for patients with congenital microtia is necessary.
Methods: A quasi-trial design with non-randomized grouping was adopted. Using convenience sampling, 98 patients with congenital microtia admitted to a tertiary specialized hospital in Shanghai from May to August 2023 were included in the control group and received routine care. From September to December 2023, another 98 patients were included in the intervention group, receiving a perioperative position management program in addition to routine care. Effectiveness was evaluated using the Ear Reconstruction Effectiveness Scale, SCARED, Quality of Life Scale for Congenital External and Middle Ear Malformation Patients, SAS, Northwick Park Neck Pain Questionnaire, and Position Execution Checklist.
Read the detailed description
Auricular reconstruction remains one of the most challenging surgeries due to its delicate structures and potential complications. The reconstructed auricle is too fragile to withstand excessive pressure that will cause blood circulation disturbances or even necrosis. Clinical observations have noted that patients and their families often experience anxiety due to concerns over complications and the impact on recovery, affecting their quality of life. Furthermore, patients frequently hold their heads in a fixed position to prevent pressure on the reconstructed auricle, which results in neck stiffness, asymmetry, and limited mobility. Therefore, effective perioperative position management is crucial for improving surgical outcomes and patient prognosis and alleviating negative emotions in patients and their families.
In our study, we evaluated the clinical usefulness of a perioperative position management program designed using the ADDIE model for patients with microtia. The patients were divided into the experimental group（98 cases）and control group （98 cases）in a quasi-experimental design that used non-randomized grouping. The experimental group received the perioperative position management program in addition to routine care. Key elements included perioperative postural management, preoperative sleeping posture adaptability training, neck movement training, standardization of head position angles and head suspension time during surgery, use of protective headrests, attention to transfer and handover procedures, and specially designed pillows.
- Conditions
- Congenital Microtia
- Being tested
- Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.
- Keywords
- Congenital microtia, Position management
- Medical subject headings
- Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.Procedure or surgery
Key elements included formation of a multidisciplinary team，perioperative postural management, preoperative sleeping posture adaptability training, neck movement training, standardization of head position angles and head suspension time during surgery, use of protective headrests, attention to transfer and handover procedures, and specially designed pillows.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group implemented a perioperative position management program for congenital microtia based on the ADDIE model, in addition to routine position care. Receives: Procedure: Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model. |
| Control Group | No intervention | The control group received routine position care, which included perioperative verbal emphasis on the importance of position by nurses, intraoperative use of hydrocolloid positioning pads to prevent pressure injuries, postoperative nurse monitoring and encouragement of proper positioning, assistance with bed mobility, and guidance on safe ambulation techniques. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ear Reconstruction Effectiveness Scale
Evaluation was conducted using the surgical outcome scoring system developed by Wei Lü. The scale includes five aspects: (1) The size, position, and realism of the reconstructed ear compared to the healthy side (total score 24 points). (2) The angle size and stability of the cranioauricular angle of the reconstructed ear (total score 12 points). (3) The color of the skin of the reconstructed ear and its coordination with the surrounding skin (total score 10 points). (4) The condition of the local scars at the incision behind the ear (total score 9 points). (5) The presentation of the subunit structure of the reconstructed ear (total score 45 points). A total score greater than 85 is rated as excellent; 75-84 is rated as good; 65-74 is rated as fair; and less than 65 is rated as poor. The specific method of use involves plastic surgeons scoring based on the structure of the child's healthy side or the structure of a normal person's auricle.
Measured: 3 months postoperatively.
Incidence of skin and flap-related complications after ear reconstruction
The researchers independently designed the position execution checklist based on a review of relevant literature. The checklist consists of two parts: (1) Demographic Information: This includes gender, age, education level, and caregivers. (2)Disease-Related Information: This includes the duration of surgery, the side of the surgery, the name of the surgery, instances of reconstructed ear compression, the time period during which the compression occurred, the occurrence of complications, and medication usage.
Measured: 3 months postoperatively.
Secondary outcomes (4)
Quality of Life Scale for Congenital External and Middle Ear Malformation Patients
This scale is used to assess the quality of life of patients with congenital middle and outer ear deformities, encompassing three dimensions: physical function, psychological state, and social relationships, with a total of 18 items. Each item is rated on a five-point scale from 0 to 4, with a total score ranging from 0 to 80. The higher the score, the poorer the quality of life.
Measured: Within 24 hours prior to discharge.
Northwick Park Neck Pain Questionnaire (NPQ)
This scale is used to assess the function of clinical neck pain patients and consists of 9 items, including pain severity, duration of symptoms, nighttime prickling or numbness, the impact of pain on sleep, social activities, reading, work or household tasks, and driving. If the subject has no driving experience, this item is not scored. Each item is rated on a five-point scale from 0 to 4, with a total score ranging from 0 to 36. The higher the score, the more severe the neck pain.
Measured: Within 24 hours prior to discharge.
Screen for Child Anxiety Related Emotional Disorders (SCARED)
This scale is used for self-assessment of anxiety disorders in children and adolescents aged 8-16. It includes five factors: somatization/panic, generalized anxiety, separation anxiety, social phobia, and school phobia, with a total of 41 items. Each item is scored on a three-point scale from 0 to 2. 0: no problem; 1: sometimes; 2: often. The higher the score, the more severe the anxiety.
Measured: Within 24 hours prior to discharge.
Self-Rating Anxiety Scale (SAS)
This scale is used to assess subjective feelings of anxiety and consists of 20 items. Each item is scored on a four-point scale. Five items (items 5, 9, 13, 17, 19) are positively worded, while the remaining 15 items are negatively worded. Patients' families use the Self-Rating Anxiety Scale (SAS) for evaluation, with scores interpreted as follows: less than 50 indicates no anxiety, 50-59 indicates mild anxiety, 60-69 indicates moderate anxiety, and greater than 69 indicates severe anxiety. Higher scores reflect more severe anxiety.
Measured: Within 24 hours prior to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 May 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Congenital MicrotiaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were grouped based on admission time to avoid contamination between groups, with data collection for the intervention group conducted after the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569927
- Sponsor's protocol ID
- FNF202312
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abuhassna, H., Alnawajha, S., Awae, F., Adnan, M., & Edwards, B. (2024). Synthesizing technology integration within the Addie model for instructional design: A comprehensive systematic literature review. Journal of Autonomous Intelligence, 7(5), 1-28. https://doi.org/https://doi.org/10.32629/jai.v7i5.1546
Ayhan H, Tastan S, Iyigun E, Ozturk E, Yildiz R, Gorgulu S. The Effectiveness of Neck Stretching Exercises Following Total Thyroidectomy on Reducing Neck Pain and Disability: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2016 Jun;13(3):224-31. doi: 10.1111/wvn.12136. Epub 2016 Jan 15.
PubMed 26773539Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
PubMed 28666405Chen X, Ma J, Zhang T. Genetics and Epigenetics in the Genesis and Development of Microtia. J Craniofac Surg. 2024 Feb 12;35(3):e261-6. doi: 10.1097/SCS.0000000000010004. Online ahead of print.
PubMed 38345940Chen X, Zhang R, Zhang Q, Xu Z, Xu F, Li D, Li Y. Microtia Part II: Post-Operation and Complications Management Lessons from 1012 Ear Reconstruction Operations. Aesthetic Plast Surg. 2022 Dec;46(6):2790-2796. doi: 10.1007/s00266-022-03010-6. Epub 2022 Jul 14.
PubMed 35835875Deng K, Dai L, Yi L, Deng C, Li X, Zhu J. Epidemiologic characteristics and time trend in the prevalence of anotia and microtia in China. Birth Defects Res A Clin Mol Teratol. 2016 Feb;106(2):88-94. doi: 10.1002/bdra.23462. Epub 2015 Dec 17.
PubMed 26681129Fan Y, Liu W, Fan X, Niu X, Chen X. Psychosocial status of patients with unilateral and bilateral microtia before auricular reconstruction surgery. Int J Pediatr Otorhinolaryngol. 2021 Dec;151:110928. doi: 10.1016/j.ijporl.2021.110928. Epub 2021 Sep 25.
PubMed 34607045Han SE, Oh KS. Satisfactory surgical option for cartilage graft absorption in microtia reconstruction. J Craniomaxillofac Surg. 2016 Apr;44(4):471-8. doi: 10.1016/j.jcms.2015.12.015. Epub 2016 Jan 6.
PubMed 26857756Li H, Wang Y, Qian J, Wang B, Liu T, Zhang Q. A Two-Stage Method for Adult Congenital Microtia: The Essentials of 15-Year Experience. Laryngoscope. 2023 Sep;133(9):2148-2153. doi: 10.1002/lary.30531. Epub 2022 Dec 20.
PubMed 36537375Li Q, Zhou X, Wang Y, Qian J, Zhang Q. Auricular reconstruction of congenital microtia by using the modified Nagata method: Personal 10-Year experience with 1350 cases. J Plast Reconstr Aesthet Surg. 2018 Oct;71(10):1462-1468. doi: 10.1016/j.bjps.2018.05.036. Epub 2018 Jun 19.
PubMed 30097399Nuyen BA, Kandathil CK, Saltychev M, Firmin F, Most SP, Truong MT. The Social Perception of Microtia and Auricular Reconstruction. Laryngoscope. 2021 Jan;131(1):195-200. doi: 10.1002/lary.28619. Epub 2020 Apr 10.
PubMed 32275329Patel KR, Benchetrit L, Ronner EA, Occhiogrosso J, Hadlock T, Shaye D, Quesnel AM, Cohen MS. Development of an interdisciplinary microtia-atresia care model: A single-center 20-year experience. Laryngoscope Investig Otolaryngol. 2022 Nov 16;7(6):2103-2111. doi: 10.1002/lio2.896. eCollection 2022 Dec.
PubMed 36544952Sevillano-Jimenez A, Romero-Saldana M, Molina-Recio G. Nursing role on rapid recovery programmes fast-track. Enferm Clin (Engl Ed). 2017 Jul 27:S1130-8621(17)30098-0. doi: 10.1016/j.enfcli.2017.06.002. Online ahead of print. English, Spanish.
PubMed 28757097Turhan Damar H, Ogce Aktas F. Anxiety, Depression, Stress, and Self-Esteem in Turkish Parents of Children with Microtia. Cleft Palate Craniofac J. 2024 Dec;61(12):1981-1990. doi: 10.1177/10556656231190046. Epub 2023 Jul 24.
PubMed 37488938Behrens B, Swetlitz C, Pine DS, Pagliaccio D. The Screen for Child Anxiety Related Emotional Disorders (SCARED): Informant Discrepancy, Measurement Invariance, and Test-Retest Reliability. Child Psychiatry Hum Dev. 2019 Jun;50(3):473-482. doi: 10.1007/s10578-018-0854-0.
PubMed 30460424
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Effectiveness of the Perioperative Position Management Based on the ADDIE Model in Patients With Congenital Microtia
- ClinicalTrials.gov ID
- NCT06569927
- Acronym / sponsor ID
- FNF202312
- Conditions
- Congenital Microtia
- Keywords
- Congenital microtia, Position management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Aug 2024 (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.
Aims and objectives: To evaluate the clinical application and effectiveness of a perioperative position management program constructed using the ADDIE model for patients with congenital microtia.
Background: The primary challenge in auricular reconstruction is the fragility of the reconstructed ear structure, necessitating strict avoidance of postoperative pressure to ensure the surgery's effect. Clinically, this has been found to cause anxiety in patients and their families. Some patients maintain a fixed position to avoid pressure on the reconstructed ear, which may lead to restricted neck movement and a high risk of pressure-related injuries. Therefore, a systematic perioperative position management program for patients with congenital microtia is necessary.
Methods: A quasi-trial design with non-randomized grouping was adopted. Using convenience sampling, 98 patients with congenital microtia admitted to a tertiary specialized hospital in Shanghai from May to August 2023 were included in the control group and received routine care. From September to December 2023, another 98 patients were included in the intervention group, receiving a perioperative position management program in addition to routine care. Effectiveness was evaluated using the Ear Reconstruction Effectiveness Scale, SCARED, Quality of Life Scale for Congenital External and Middle Ear Malformation Patients, SAS, Northwick Park Neck Pain Questionnaire, and Position Execution Checklist.
Detailed description
Auricular reconstruction remains one of the most challenging surgeries due to its delicate structures and potential complications. The reconstructed auricle is too fragile to withstand excessive pressure that will cause blood circulation disturbances or even necrosis. Clinical observations have noted that patients and their families often experience anxiety due to concerns over complications and the impact on recovery, affecting their quality of life. Furthermore, patients frequently hold their heads in a fixed position to prevent pressure on the reconstructed auricle, which results in neck stiffness, asymmetry, and limited mobility. Therefore, effective perioperative position management is crucial for improving surgical outcomes and patient prognosis and alleviating negative emotions in patients and their families.
In our study, we evaluated the clinical usefulness of a perioperative position management program designed using the ADDIE model for patients with microtia. The patients were divided into the experimental group（98 cases）and control group （98 cases）in a quasi-experimental design that used non-randomized grouping. The experimental group received the perioperative position management program in addition to routine care. Key elements included perioperative postural management, preoperative sleeping posture adaptability training, neck movement training, standardization of head position angles and head suspension time during surgery, use of protective headrests, attention to transfer and handover procedures, and specially designed pillows.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects were grouped based on admission time to avoid contamination between groups, with data collection for the intervention group conducted after the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.The intervention group implemented a perioperative position management program for congenital microtia based on the ADDIE model, in addition to routine position care. |
| Control Group | No intervention | –The control group received routine position care, which included perioperative verbal emphasis on the importance of position by nurses, intraoperative use of hydrocolloid positioning pads to prevent pressure injuries, postoperative nurse monitoring and encouragement of proper positioning, assistance with bed mobility, and guidance on safe ambulation techniques. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of congenital microtia according to the "Chinese Plastic Surgery" criteria, and undergoing ear reconstruction.
- No other severe comorbidities.
Key exclusion criteria (4 listed)
- Abnormal coagulation function.
- Presence of eczema or infection on the affected side.
- Severe cognitive impairment or mental illness.
- Patient or family disagrees with the study.
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 |
|---|---|---|
| Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model.Key elements included formation of a multidisciplinary team，perioperative postural management, preoperative sleeping posture adaptability training, neck movement training, standardization of head position angles and head suspension time during surgery, use of protective headrests, attention to transfer and handover procedures, and specially designed pillows. | Procedure or surgery | Intervention group |
Primary outcome
Ear Reconstruction Effectiveness Scale
Time frame: 3 months postoperatively.
Evaluation was conducted using the surgical outcome scoring system developed by Wei Lü. The scale includes five aspects: (1) The size, position, and realism of the reconstructed ear compared to the healthy side (total score 24 points). (2) The angle size and stability of the cranioauricular angle of the reconstructed ear (total score 12 points). (3) The color of the skin of the reconstructed ear and its coordination with the surrounding skin (total score 10 points). (4) The condition of the local scars at the incision behind the ear (total score 9 points). (5) The presentation of the subunit structure of the reconstructed ear (total score 45 points). A total score greater than 85 is rated as excellent; 75-84 is rated as good; 65-74 is rated as fair; and less than 65 is rated as poor. The specific method of use involves plastic surgeons scoring based on the structure of the child's healthy side or the structure of a normal person's auricle.
Incidence of skin and flap-related complications after ear reconstruction
Time frame: 3 months postoperatively.
The researchers independently designed the position execution checklist based on a review of relevant literature. The checklist consists of two parts: (1) Demographic Information: This includes gender, age, education level, and caregivers. (2)Disease-Related Information: This includes the duration of surgery, the side of the surgery, the name of the surgery, instances of reconstructed ear compression, the time period during which the compression occurred, the occurrence of complications, and medication usage.
4 secondary outcomes
Quality of Life Scale for Congenital External and Middle Ear Malformation Patients
Time frame: Within 24 hours prior to discharge.
Northwick Park Neck Pain Questionnaire (NPQ)
Time frame: Within 24 hours prior to discharge.
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: Within 24 hours prior to discharge.
Self-Rating Anxiety Scale (SAS)
Time frame: Within 24 hours prior to discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- BackgroundAbuhassna, H., Alnawajha, S., Awae, F., Adnan, M., & Edwards, B. (2024). Synthesizing technology integration within the Addie model for instructional design: A comprehensive systematic literature review. Journal of Autonomous Intelligence, 7(5), 1-28. https://doi.org/https://doi.org/10.32629/jai.v7i5.1546
- Background: PubMed 26773539Ayhan H, Tastan S, Iyigun E, Ozturk E, Yildiz R, Gorgulu S. The Effectiveness of Neck Stretching Exercises Following Total Thyroidectomy on Reducing Neck Pain and Disability: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2016 Jun;13(3):224-31. doi: 10.1111/wvn.12136. Epub 2016 Jan 15.
- Background: PubMed 28666405Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
- Background: PubMed 38345940Chen X, Ma J, Zhang T. Genetics and Epigenetics in the Genesis and Development of Microtia. J Craniofac Surg. 2024 Feb 12;35(3):e261-6. doi: 10.1097/SCS.0000000000010004. Online ahead of print.
- Background: PubMed 35835875Chen X, Zhang R, Zhang Q, Xu Z, Xu F, Li D, Li Y. Microtia Part II: Post-Operation and Complications Management Lessons from 1012 Ear Reconstruction Operations. Aesthetic Plast Surg. 2022 Dec;46(6):2790-2796. doi: 10.1007/s00266-022-03010-6. Epub 2022 Jul 14.
- Background: PubMed 26681129Deng K, Dai L, Yi L, Deng C, Li X, Zhu J. Epidemiologic characteristics and time trend in the prevalence of anotia and microtia in China. Birth Defects Res A Clin Mol Teratol. 2016 Feb;106(2):88-94. doi: 10.1002/bdra.23462. Epub 2015 Dec 17.
- Background: PubMed 34607045Fan Y, Liu W, Fan X, Niu X, Chen X. Psychosocial status of patients with unilateral and bilateral microtia before auricular reconstruction surgery. Int J Pediatr Otorhinolaryngol. 2021 Dec;151:110928. doi: 10.1016/j.ijporl.2021.110928. Epub 2021 Sep 25.
- Background: PubMed 26857756Han SE, Oh KS. Satisfactory surgical option for cartilage graft absorption in microtia reconstruction. J Craniomaxillofac Surg. 2016 Apr;44(4):471-8. doi: 10.1016/j.jcms.2015.12.015. Epub 2016 Jan 6.
- Background: PubMed 36537375Li H, Wang Y, Qian J, Wang B, Liu T, Zhang Q. A Two-Stage Method for Adult Congenital Microtia: The Essentials of 15-Year Experience. Laryngoscope. 2023 Sep;133(9):2148-2153. doi: 10.1002/lary.30531. Epub 2022 Dec 20.
- Background: PubMed 30097399Li Q, Zhou X, Wang Y, Qian J, Zhang Q. Auricular reconstruction of congenital microtia by using the modified Nagata method: Personal 10-Year experience with 1350 cases. J Plast Reconstr Aesthet Surg. 2018 Oct;71(10):1462-1468. doi: 10.1016/j.bjps.2018.05.036. Epub 2018 Jun 19.
- Background: PubMed 32275329Nuyen BA, Kandathil CK, Saltychev M, Firmin F, Most SP, Truong MT. The Social Perception of Microtia and Auricular Reconstruction. Laryngoscope. 2021 Jan;131(1):195-200. doi: 10.1002/lary.28619. Epub 2020 Apr 10.
- Background: PubMed 36544952Patel KR, Benchetrit L, Ronner EA, Occhiogrosso J, Hadlock T, Shaye D, Quesnel AM, Cohen MS. Development of an interdisciplinary microtia-atresia care model: A single-center 20-year experience. Laryngoscope Investig Otolaryngol. 2022 Nov 16;7(6):2103-2111. doi: 10.1002/lio2.896. eCollection 2022 Dec.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Utilization of a perioperative position management protocol for congenital microtia patients based on the ADDIE model. in people with Congenital Microtia, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ear Reconstruction Effectiveness Scale (time frame: 3 months postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06569927, which also lists 19 linked publications.
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 26 Aug 2024.