Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring

Not Applicable

Completed

• Conditions: Scar
• Interventions: Device: Tension reduction device

• Registration Number: NCT03842644
• Lead Sponsor: XiaoXi Lin

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.

Detailed Description

Primary measurement: the mean scar width calculated by standard photos with rulers.

Secondary measure: the probability of scar hyperplasia.

Study Timeline

• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-02-16
• Status Verified: 2020-10
• Primary Completion: 2020-10-25
• Study Completion: 2020-10-25
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• The incision is not shorter than 3cm
• Skin type is III/IV

Exclusion Criteria

• Any medical history of facial surgery, not included injection therapy, external medication or fat graft
• Unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear
• Patients with a history of keloid or family history of keloid
• Patients with serious skin disorders, eg. serious psoriasis or dermatitis
• Patients with severe systemic or congenital disease which may affect the patient's safety in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tension Reduction	Tension reduction device	Tension reduction device for 3 months post surgery

Primary Outcome Measures

Name	Time	Method
Scar width	through study completion, an average of 1 year	scar width is measure by standard photo with ruler

Secondary Outcome Measures

Name	Time	Method
Vancouver Scar Scale	through study completion, an average of 1 year	total score range from 0 to 14, the score14 is considered as the worse outcome
Hypertrophic scar rate	through study completion, an average of 1 year	The onset of hypertrophic scar will be documented in the time of follow-up. The red and stiffness scar which higher than the surrounding skin surface will be considered as hypertrophic scar.
Patient and observer scar assessment scale score	through study completion, an average of 1 year	Subscale 1: observer scar assessment scale (score range 5-50), the score 50 is considered as the worse outcome.; Subscale 2: patient scar assessment scale (score range 5-50), the score 50 is considered as the worse outcome.
Relative side effect	through study completion, an average of 1 year	The relative side effect will be documented in each time of follow-up.

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China