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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe head and face deformity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Severe head and face deformity reconstructive surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 2 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tao Zan, MD, PhD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | 200011 | China |
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