Scar
Conditions
Keywords
Tension Reduction
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.
Interventions
DEVICETension reduction device
Continue using this device for 3 months post surgery.
Sponsors
XiaoXi Lin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar width | through study completion, an average of 1 year | scar width is measure by standard photo with ruler |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Relative side effect | through study completion, an average of 1 year | The relative side effect will be documented in each time of follow-up. |
Countries
China
Outcome results
None listed