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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842644
• Other study ID #: SH9H-2018-T65-2
• Status: Completed
• Phase: N/A
• Start date: February 16, 2019
• Est. completion date: October 25, 2020

Study information

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

Clinical Trial 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.

Description:

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

Secondary measure: the probability of scar hyperplasia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 25, 2020
• Est. primary completion date: October 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Scar

Intervention

Device:
• Tension reduction device
Continue using this device for 3 months post surgery.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
XiaoXi Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar width	scar width is measure by standard photo with ruler	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Relative side effect	The relative side effect will be documented in each time of follow-up.	through study completion, an average of 1 year