Completed

NCT Number: NCT04405687

Postoperative Follow up After Head and Face Reconstructive Surgeries

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.

Completed

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Key information

Conditions

Deformity of Face

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

Post-reconstructive Surgeries of Severe Head and Face Deformities: An Observational Follow-up Study

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: May 28, 2020
Registry last updated: Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.