Postoperative Skin Surface Tension Relaxing in Prevention... | NCT03842644

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

NCT03842644

Sponsor

XiaoXi Lin

Status

Completed

Last Update Posted

Oct 29, 2020Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Scar

Interventions

Tension reduction device

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2019Actual

Primary Completion Date

Oct 25, 2020Actual

Completion Date

Oct 25, 2020Actual

First Submitted Date

Feb 2, 2019

First Submission Date that Met QC Criteria

Feb 13, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2020

Last Update Posted Date

Oct 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

XiaoXi Lin, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversitySponsor-Investigator

Lead Sponsor

XiaoXi LinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tension Reduction	Experimental	Tension reduction device for 3 months post surgery	Device: Tension reduction device
Control	No Intervention	No tension reduction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tension reduction device	Device	Continue using this device for 3 months post surgery.	Tension Reduction

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lin, Professor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine		Shanghai	Shanghai Municipality	200011	China

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided