Postoperative Follow up After Head and Face Reconstructive Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Deformity of Face
• Intervention / Treatment: Procedure: Severe head and face deformity reconstructive surgery

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Severe head and face deformity

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Study Director: Tao Zan, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2020
• Primary Completion (ACTUAL): April 18, 2020
• Study Completion (ACTUAL): April 18, 2020

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (ACTUAL): May 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Follow Up

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No