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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03842644
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
XiaoXi Lin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Scar Device: Tension reduction device Not Applicable

Detailed Description:

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

Secondary measure: the probability of scar hyperplasia.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.
Actual Study Start Date : February 16, 2019
Actual Primary Completion Date : October 25, 2020
Actual Study Completion Date : October 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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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 Name: Zipline Surgical Skin Closure Device
No Intervention: Control
No tension reduction


Outcome Measures
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Primary Outcome Measures :
  1. Scar width [ Time Frame: through study completion, an average of 1 year ]
    scar width is measure by standard photo with ruler


Secondary Outcome Measures :
  1. Hypertrophic scar rate [ Time Frame: through study completion, an average of 1 year ]
    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.

  2. Patient and observer scar assessment scale score [ Time Frame: through study completion, an average of 1 year ]

    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.


  3. Vancouver Scar Scale [ Time Frame: through study completion, an average of 1 year ]
    total score range from 0 to 14, the score14 is considered as the worse outcome

  4. Relative side effect [ Time Frame: through study completion, an average of 1 year ]
    The relative side effect will be documented in each time of follow-up.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842644


Locations
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China, Shanghai
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
XiaoXi Lin
Investigators
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Principal Investigator: Lin, Professor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
More Information
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Responsible Party: XiaoXi Lin, Professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03842644    
Other Study ID Numbers: SH9H-2018-T65-2
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by XiaoXi Lin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Tension Reduction
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes