About this trial
The purpose of this study is to evaluate the efficacy and safety of a disposable noninvasive skin closure device in promoting postoperative wound healing and reducing surgical scar formation. Participants will receive the device on one half of the surgical incision, with the other half serving as a control. Wound healing and scar appearance will be assessed during follow-up visits after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 20 to 50 years undergoing plastic surgery
Surgical incision located on the cheek, neck, trunk, or limbs, excluding the hands and feet
Surgical incision longer than 2 cm
Willing and able to provide written informed consent
Disqualifiers
History of abnormal scar formation or keloids
Autoimmune disease
Surgical wound infection
Use of any scar treatment or wound treatment other than the study device during the study period
Trial design
Parallel
Treatments tested in this trial
Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF)
DeviceA disposable noninvasive skin closure device will be applied to the randomly assigned half of each participant's surgical incision after routine suturing. The device is designed to reduce tension across the skin surface without penetrating the skin. It will be used continuously for 3 months after surgery, while the other half of the incision will receive routine postoperative care without tension-reduction treatment.
Treatment groups
Trial outcomes
Primary outcomes
Vancouver Scar Scale (VSS) score
Blinded plastic surgeons will assess each half of the surgical incision using the VSS. Lower scores indicate a better scar outcome.
Secondary outcomes
Modified Patient and Observer Scar Assessment Scale (mPOSAS) score
Blinded plastic surgeons will assess scar appearance for each half of the surgical incision using the mPOSAS. Lower scores indicate a better scar outcome.
Device-related adverse events
Skin redness, itching, and other adverse events related to use of the disposable noninvasive skin closure device will be recorded.
Sponsors and contacts
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