Postoperative Follow up After Head and Face Reconstructive Surgeries

Completed

• Conditions: Deformity of Face
• Interventions: Procedure: Severe head and face deformity reconstructive surgery

• Registration Number: NCT04405687
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief 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.

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 Timeline

• Study Start: 2020-03-10
• Primary Completion: 2020-04-18
• Study Completion: 2020-04-18
• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-28
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe head and face deformity	Severe head and face deformity reconstructive surgery	-

Primary Outcome Measures

Name	Time	Method
SF-36 total score	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)	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	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.

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, Shanghai, China