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

NCT ID: NCT03842644

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-16

Study Completion Date

2020-10-25

Brief Summary

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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

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

Secondary measure: the probability of scar hyperplasia.

Conditions

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Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tension Reduction

Tension reduction device for 3 months post surgery

Group Type EXPERIMENTAL

Tension reduction device

Intervention Type DEVICE

Continue using this device for 3 months post surgery.

Control

No tension reduction

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tension reduction device

Continue using this device for 3 months post surgery.

Intervention Type DEVICE

Other Intervention Names

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Zipline Surgical Skin Closure Device

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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XiaoXi Lin

OTHER

Sponsor Role lead

Responsible Party

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XiaoXi Lin

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lin, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SH9H-2018-T65-2

Identifier Type: -

Identifier Source: org_study_id