NCT03842644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

February 16, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

February 2, 2019

Last Update Submit

October 28, 2020

Conditions

Scar

Keywords

Tension Reduction

Outcome Measures

Primary Outcomes (1)

  • Scar width

    scar width is measure by standard photo with ruler

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Hypertrophic scar rate

    through study completion, an average of 1 year

  • Patient and observer scar assessment scale score

    through study completion, an average of 1 year

  • Vancouver Scar Scale

    through study completion, an average of 1 year

  • Relative side effect

    through study completion, an average of 1 year

Study Arms (2)

Tension Reduction

EXPERIMENTAL

Tension reduction device for 3 months post surgery

Device: Tension reduction device

Control

NO INTERVENTION

No tension reduction

Interventions

Tension reduction deviceDEVICE

Continue using this device for 3 months post surgery.

Also known as: Zipline Surgical Skin Closure Device
Tension Reduction

Eligibility Criteria

Age6 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The incision is not shorter than 3cm
  • Skin type is III/IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lin, Professor

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 15, 2019

Study Start

February 16, 2019

Primary Completion

October 25, 2020

Study Completion

October 25, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

CN(1)