ScarNCT07849010
Disposable Noninvasive Skin Closure for Promoting Postoperative Wound Healing and Preventing Surgical Skin Scarring
A study testing Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF) in people with Scar, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Scar
- What is being tested?
- Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Mengying Jin, M.D., +86 18811331677, 1510301328@pku.edu.cn
About this study
Official title: Disposable Noninvasive Skin Closure for Promoting Postoperative Wound Healing and Preventing Surgical Skin Scarring: A Single-Center, Prospective, Randomized Split-Scar, Self-Controlled Clinical 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.
Read the detailed description
Surgical wounds can heal with visible scars. Tension on the skin may affect wound healing and scar formation. This study will evaluate whether a disposable noninvasive skin closure device can improve healing and reduce scar formation after plastic surgery.
Adults undergoing plastic surgery with an incision longer than 2 cm on the cheek, neck, trunk, or limbs will be enrolled. Each participant's incision will be divided into two parts. By random assignment, the device will be applied to one part of the incision, while the other part will receive standard postoperative care without the device. This within-participant comparison allows each participant to serve as their own control.
Participants will return for assessments at 1, 3, and 6 months after surgery. Blinded plastic surgeons will assess wound healing and scar appearance using standardized scar-rating tools. The study will evaluate whether the device is safe and effective for supporting postoperative wound healing and preventing surgical scar formation.
- Conditions
- Scar
- Being tested
- Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF)
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Tension Reduction | Experimental | The disposable noninvasive skin closure device will be applied to the randomly assigned half of the surgical incision for 3 months after surgery. Receives: Device: Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF) |
| Control | No intervention | The other half of the same surgical incision will receive routine postoperative care without the disposable noninvasive skin closure device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (2)
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.
Measured: 1, 3, and 6 months after surgery
Device-related adverse events
Skin redness, itching, and other adverse events related to use of the disposable noninvasive skin closure device will be recorded.
Measured: 1, 3, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start8 Oct 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SunYimou, Peking University Third Hospital
- Investigators
- Yimou Sun, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849010
- Sponsor's protocol ID
- M2024719
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32117656Gorsulowsky 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.
PubMed 26218731Tanaka 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.
PubMed 27261084Kjonniksen 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.
PubMed 8137286Gold 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.
PubMed 25068544Gold 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.
PubMed 25068543
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposable Noninvasive Skin Closure for Promoting Postoperative Wound Healing and Preventing Surgical Skin Scarring: A Single-Center, Prospective, Randomized Split-Scar, Self-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07849010
- Acronym / sponsor ID
- M2024719
- Conditions
- Scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Surgical wounds can heal with visible scars. Tension on the skin may affect wound healing and scar formation. This study will evaluate whether a disposable noninvasive skin closure device can improve healing and reduce scar formation after plastic surgery.
Adults undergoing plastic surgery with an incision longer than 2 cm on the cheek, neck, trunk, or limbs will be enrolled. Each participant's incision will be divided into two parts. By random assignment, the device will be applied to one part of the incision, while the other part will receive standard postoperative care without the device. This within-participant comparison allows each participant to serve as their own control.
Participants will return for assessments at 1, 3, and 6 months after surgery. Blinded plastic surgeons will assess wound healing and scar appearance using standardized scar-rating tools. The study will evaluate whether the device is safe and effective for supporting postoperative wound healing and preventing surgical scar formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension Reduction | Experimental | Device: Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF)The disposable noninvasive skin closure device will be applied to the randomly assigned half of the surgical incision for 3 months after surgery. |
| Control | No intervention | –The other half of the same surgical incision will receive routine postoperative care without the disposable noninvasive skin closure device. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF)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. | Device | Tension Reduction |
Primary outcome
Vancouver Scar Scale (VSS) score
Time frame: 6 months after surgery
Blinded plastic surgeons will assess each half of the surgical incision using the VSS. Lower scores indicate a better scar outcome.
2 secondary outcomes
Modified Patient and Observer Scar Assessment Scale (mPOSAS) score
Time frame: 1, 3, and 6 months after surgery
Device-related adverse events
Time frame: 1, 3, and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 32117656Menkowitz 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.
- Background: PubMed 26218731Gorsulowsky 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.
- Background: PubMed 27261084Tanaka 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.
- Background: PubMed 8137286Kjonniksen 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.
- Background: PubMed 25068544Gold 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.
- Background: PubMed 25068543Gold 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yimou Sun, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable Noninvasive Skin Closure Device (Shanghai Zhizhong Medical Technology Co., Ltd. Catalog No.: 240430PFF) in people with Scar, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yimou Sun, M.D. (+86 13811625471, sym316@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) score (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07849010, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.