Postoperative Follow up After Head and Face Reconstructive Surgeries

Deformity of Face Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405687
• Other study ID #: Follow Up
• Status: Completed
• Start date: March 10, 2020
• Est. completion date: April 18, 2020

Study information

• Verified date: May 2020
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 18, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Deformity of Face

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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