Postoperative Follow up After Head and Face Reconstructive Surgeries

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Deformity of Face

Interventions

Severe head and face deformity reconstructive surgeryPROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Preoperative facial soft tissue deformities/defects of type III and IV 2. Major reconstructive surgery of the head and neck (flap transfer with revision at least once) performed before January 1, 2019. 3. Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent. Exclusion Criteria: 1. Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate. 2. Minor patients without legal guardian. 3. Not willing to participate; informed consent form not signed.

Locations (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 minutes

Data from ClinicalTrials.gov

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