Disposable Noninvasive Skin Closure for Promoting Postoperative Wound Healing and Preventing Surgical Skin Scarring

ConditionScar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorPeking University Third Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF)

    Device

    A 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

25 Participants
are divided into 2 treatment groups
Group A: Tension ReductionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months after surgery

Secondary outcomes

1

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.

Time frame
1, 3, and 6 months after surgery
2

Device-related adverse events

Skin redness, itching, and other adverse events related to use of the disposable noninvasive skin closure device will be recorded.

Time frame
1, 3, and 6 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.