Back to resultsPostoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring
Primary Purpose
Scar
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tension reduction device
Sponsored by
About this trial
This is an interventional prevention trial for Scar focused on measuring Tension Reduction
Eligibility Criteria
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
Sites / Locations
- Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tension Reduction
Control
Arm Description
Tension reduction device for 3 months post surgery
No tension reduction
Outcomes
Primary Outcome Measures
Scar width
scar width is measure by standard photo with ruler
Secondary Outcome Measures
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.
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.
Vancouver Scar Scale
total score range from 0 to 14, the score14 is considered as the worse outcome
Relative side effect
The relative side effect will be documented in each time of follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03842644
Brief Title
Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring
Official Title
Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 16, 2019 (Actual)
Primary Completion Date
October 25, 2020 (Actual)
Study Completion Date
October 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
XiaoXi Lin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
Tension Reduction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tension Reduction
Arm Type
Experimental
Arm Description
Tension reduction device for 3 months post surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
No tension reduction
Intervention Type
Device
Intervention Name(s)
Tension reduction device
Other Intervention Name(s)
Zipline Surgical Skin Closure Device
Intervention Description
Continue using this device for 3 months post surgery.
Primary Outcome Measure Information:
Title
Scar width
Description
scar width is measure by standard photo with ruler
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Hypertrophic scar rate
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Patient and observer scar assessment scale score
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Vancouver Scar Scale
Description
total score range from 0 to 14, the score14 is considered as the worse outcome
Time Frame
through study completion, an average of 1 year
Title
Relative side effect
Description
The relative side effect will be documented in each time of follow-up.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin, Professor
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Learn more about this trial
Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring
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