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

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

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.

Study Overview

• Status: Completed
• Conditions: Scar
• Intervention / Treatment: Device: Tension reduction device

Detailed Description

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

Secondary measure: the probability of scar hyperplasia.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tension Reduction; Tension reduction device for 3 months post surgery	Device: Tension reduction device; Continue using this device for 3 months post surgery.; Other Names: Zipline Surgical Skin Closure Device
No Intervention: Control; No tension reduction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: XiaoXi Lin
• Investigators: Principal Investigator: Lin, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2019
• Primary Completion (Actual): October 25, 2020
• Study Completion (Actual): October 25, 2020

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Tension Reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: SH9H-2018-T65-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No