Disposable Noninvasive Skin Closure for Promoting Postoperative Wound Healing and Preventing Surgical Skin Scarring
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2026
CompletedFirst Posted
Study publicly available on registry
September 30, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
September 30, 2026
September 1, 2026
9 months
September 22, 2026
September 29, 2026
Conditions
Outcome Measures
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.
6 months after surgery
Secondary Outcomes (2)
Modified Patient and Observer Scar Assessment Scale (mPOSAS) score
1, 3, and 6 months after surgery
Device-related adverse events
1, 3, and 6 months after surgery
Study Arms (2)
Tension Reduction
EXPERIMENTALThe disposable noninvasive skin closure device will be applied to the randomly assigned half of the surgical incision for 3 months after surgery.
Control
NO INTERVENTIONThe other half of the same surgical incision will receive routine postoperative care without the disposable noninvasive skin closure device.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Related Publications (6)
Menkowitz B, Olivieri G, Belson O. Patient Satisfaction and Cosmetic Outcome in a Randomized, Prospective Study of Total Knee Arthroplasty Skin Closure Comparing Zip Surgical Skin Closure with Staples. Cureus. 2020 Jan 19;12(1):e6705. doi: 10.7759/cureus.6705.
PMID: 32117656BACKGROUNDGorsulowsky DC, Talmor G. A novel noninvasive wound closure device as the final layer in skin closure. Dermatol Surg. 2015 Aug;41(8):987-9. doi: 10.1097/DSS.0000000000000399. No abstract available.
PMID: 26218731BACKGROUNDTanaka Y, Miyamoto T, Naito Y, Yoshitake S, Sasahara A, Miyaji K. Randomized Study of a New Noninvasive Skin Closure Device for Use After Congenital Heart Operations. Ann Thorac Surg. 2016 Oct;102(4):1368-74. doi: 10.1016/j.athoracsur.2016.03.072. Epub 2016 Jun 1.
PMID: 27261084BACKGROUNDKjonniksen I, Winderen M, Bruland O, Fodstad O. Validity and usefulness of human tumor models established by intratibial cell inoculation in nude rats. Cancer Res. 1994 Apr 1;54(7):1715-9.
PMID: 8137286BACKGROUNDGold MH, McGuire M, Mustoe TA, Pusic A, Sachdev M, Waibel J, Murcia C; International Advisory Panel on Scar Management. Updated international clinical recommendations on scar management: part 2--algorithms for scar prevention and treatment. Dermatol Surg. 2014 Aug;40(8):825-31. doi: 10.1111/dsu.0000000000000050.
PMID: 25068544BACKGROUNDGold MH, Berman B, Clementoni MT, Gauglitz GG, Nahai F, Murcia C. Updated international clinical recommendations on scar management: part 1--evaluating the evidence. Dermatol Surg. 2014 Aug;40(8):817-24. doi: 10.1111/dsu.0000000000000049.
PMID: 25068543BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yimou Sun, M.D.
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Physician
Study Record Dates
First Submitted
September 22, 2026
First Posted
September 30, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared because the study involves identifiable clinical photographs and sensitive personal health information. To protect participant privacy and confidentiality, individual participant data will remain restricted to the study team.