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

Browse trials for

• Cicatrix 306

Study arms

• Experimental
  Tension Reduction

  The disposable noninvasive skin closure device will be applied to the randomly assigned half of the surgical incision for 3 months after surgery.

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

• No intervention
  Control

  The other half of the same surgical incision will receive routine postoperative care without the disposable noninvasive skin closure device.

Interventions

• DeviceDisposable 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.

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

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 32117656 ↗
• Gorsulowsky 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 26218731 ↗
• Tanaka 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 27261084 ↗
• Kjonniksen 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 8137286 ↗
• Gold 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 25068544 ↗
• Gold 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 ↗

Individual participant data

Plan to share: 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.