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Completed

NCT Number: NCT03842644

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200011, China

About this study

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

Secondary measure: the probability of scar hyperplasia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tension reduction device

Device

Continue using this device for 3 months post surgery.

Other names: Zipline Surgical Skin Closure Device

Primary outcomes

  1. Scar width

    Time frame: through study completion, an average of 1 year

    scar width is measure by standard photo with ruler

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

XiaoXi Lin

Other

Registry information

Official study title

Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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