Postoperative Follow up After Head and Face Reconstructive Surgeries

NCT ID: NCT04405687

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-04-18

Brief Summary

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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.

Detailed Description

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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

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Deformity of Face

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Severe head and face deformity

Severe head and face deformity reconstructive surgery

Intervention Type 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.

Interventions

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Severe head and face deformity reconstructive 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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zantao

Researcher of Plastic and Reconstructive Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tao Zan, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Follow Up

Identifier Type: -

Identifier Source: org_study_id

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