Deformity of FaceNCT04405687
Postoperative Follow up After Head and Face Reconstructive Surgeries
An observational study of Deformity of Face, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
In this observational follow-up study, patients with type III-IV head and face soft tissue deformities/defects following reconstructive surgeries will be asked to fill out 3 questionnaires, either through phone calls or video calls, in order to evaluate the post-operative outcomes such as morphological and functional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deformity of Face
- What is being tested?
- Severe head and face deformity reconstructive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2020to 18 Apr 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This clinical study will include patients treated by Prof. Li Qingfeng 's professional team who have undergone major head and face reconstructive surgeries before January 1, 2019. It is estimated that about 85 patients will be enrolled in this study.
Who may be able to join
- Preoperative facial soft tissue deformities/defects of type III and IV
- Major reconstructive surgery of the head and neck (flap transfer with revision at least once) performed before January 1, 2019.
- Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.
Who cannot join
- Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
- Minor patients without legal guardian.
- Not willing to participate; informed consent form not signed.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Post-reconstructive Surgeries of Severe Head and Face Deformities: An Observational Follow-up Study
In this observational follow-up study, patients with type III-IV head and face soft tissue deformities/defects following reconstructive surgeries will be asked to fill out 3 questionnaires, either through phone calls or video calls, in order to evaluate the post-operative outcomes such as morphological and functional recovery, quality of life and patients' return to the community.
Read the detailed description
The objective of this follow up study is to evaluate the effectiveness and to analyze the limitations of the existing management and treatment of severe burn injuries. Investigation of the factors affecting the recovery and patients' return to the community in patients with severe burn injury may lead to effective amendments of the existing management, and thus aiding in the development of an integrated diagnosis and treatment guidelines.
- Conditions
- Deformity of Face
- Being tested
- Severe head and face deformity reconstructive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe head and face deformity reconstructive surgeryProcedure or surgery
Three questionnaires, including the 36-Item Short Form Health Survey questionnaire (SF-36), Aesthetic and Functional Status Score of Facial Soft-Tissue Deformities/Defects (A\&F) and Euroqol 5 dimensions 5 levels questionnaire (EQ-5D-5L), were conducted to evaluate their quality of life and satisfaction with facial aesthetic and functional status.
| Study group | Role | What they receive |
|---|---|---|
| Severe head and face deformity | Not described Receives: Procedure: Severe head and face deformity reconstructive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 total score
8 aspects including actual physiological function, desirable physiological function, somatic pain, general health status, vitality, social function, emotional function, mental health; and 1 health indicator(reported health transition) Score ranges from 1-100 for each aspects, with higher score indicating a better quality of life.
Measured: 12 minutes
Aesthetic & Functional total score (Patient edition)
3 marks for each aspect; Score ranges from 0-18 for aesthetic status, and 0-21 for functional status, with higher score indicating a better outcome.
For overall satisfaction of aesthetic and functional status preoperatively and postoperatively, score ranges from 0-10, with higher score indicating a better outcome.
Measured: 8 minutes
EQ-5D-5L total score
Assessment of the patients' mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
Score ranges from 0-100, with higher score indicating a better outcome.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start10 Mar 2020
- Primary completion18 Apr 2020
- Study completion18 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformity of FaceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zantao, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Tao Zan, MD, PhD, Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405687
- Sponsor's protocol ID
- Follow Up
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-reconstructive Surgeries of Severe Head and Face Deformities: An Observational Follow-up Study
- ClinicalTrials.gov ID
- NCT04405687
- Acronym / sponsor ID
- Follow Up
- Conditions
- Deformity of Face
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 28 May 2020 (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.
In this observational follow-up study, patients with type III-IV head and face soft tissue deformities/defects following reconstructive surgeries will be asked to fill out 3 questionnaires, either through phone calls or video calls, in order to evaluate the post-operative outcomes such as morphological and functional recovery, quality of life and patients' return to the community.
Detailed description
The objective of this follow up study is to evaluate the effectiveness and to analyze the limitations of the existing management and treatment of severe burn injuries. Investigation of the factors affecting the recovery and patients' return to the community in patients with severe burn injury may lead to effective amendments of the existing management, and thus aiding in the development of an integrated diagnosis and treatment guidelines.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe head and face deformity | – | Procedure: Severe head and face deformity reconstructive surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This clinical study will include patients treated by Prof. Li Qingfeng 's professional team who have undergone major head and face reconstructive surgeries before January 1, 2019. It is estimated that about 85 patients will be enrolled in this study.
Key inclusion criteria (3 listed)
- Preoperative facial soft tissue deformities/defects of type III and IV
- Major reconstructive surgery of the head and neck (flap transfer with revision at least once) performed before January 1, 2019.
- Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.
Key exclusion criteria (3 listed)
- Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
- Minor patients without legal guardian.
- Not willing to participate; informed consent form not signed.
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 |
|---|---|---|
| Severe head and face deformity reconstructive surgeryThree questionnaires, including the 36-Item Short Form Health Survey questionnaire (SF-36), Aesthetic and Functional Status Score of Facial Soft-Tissue Deformities/Defects (A\&F) and Euroqol 5 dimensions 5 levels questionnaire (EQ-5D-5L), were conducted to evaluate their quality of life and satisfaction with facial aesthetic and functional status. | Procedure or surgery | Severe head and face deformity |
Primary outcome
SF-36 total score
Time frame: 12 minutes
8 aspects including actual physiological function, desirable physiological function, somatic pain, general health status, vitality, social function, emotional function, mental health; and 1 health indicator(reported health transition) Score ranges from 1-100 for each aspects, with higher score indicating a better quality of life.
Aesthetic & Functional total score (Patient edition)
Time frame: 8 minutes
3 marks for each aspect; Score ranges from 0-18 for aesthetic status, and 0-21 for functional status, with higher score indicating a better outcome. For overall satisfaction of aesthetic and functional status preoperatively and postoperatively, score ranges from 0-10, with higher score indicating a better outcome.
EQ-5D-5L total score
Time frame: 2 minutes
Assessment of the patients' mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Score ranges from 0-100, with higher score indicating a better outcome.
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 1 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Tao Zan, MD, PhD study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deformity of Face, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 3 inclusion and 3 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 1 Jun 2020. 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?
SF-36 total score (time frame: 12 minutes). The study lists 3 primary outcomes in all. 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 1 Jun 2020.