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

Study Overview
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Brief Summary
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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
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Primary measurement: the mean scar width calculated by standard photos with rulers. Secondary measure: the probability of scar hyperplasia.

Official Title
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Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.

Conditions
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Scar

Intervention / Treatment
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* Device: Tension reduction device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tension Reduction<br>Tension reduction device for 3 months post surgery | Device: Tension reduction device<br>* Continue using this device for 3 months post surgery.<br>* Other names: Zipline Surgical Skin Closure Device;|
| No Intervention: Control<br>No tension reduction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar width | scar width is measure by standard photo with ruler | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertrophic scar rate | 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. | through study completion, an average of 1 year | 
| Patient and observer scar assessment scale score | 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. | through study completion, an average of 1 year | 
| Vancouver Scar Scale | total score range from 0 to 14, the score14 is considered as the worse outcome | through study completion, an average of 1 year | 
| Relative side effect | The relative side effect will be documented in each time of follow-up. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tension Reduction