Surginus

Xkin — Foldable Skin Closure (non-invasive skin closure)

Name: Xkin — Foldable Skin Closure (non-invasive skin closure)
Brand: Surginus
Availability: InStock

A non-traumatic and aesthetic alternative for wound closure, compared with thread sutures or the use of staples — featuring a dual hydrocolloid, rapid application, and an improved cosmetic result.

Medical Instruments Traumatology

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Xkin — the device applied to a surgical incision, with the align–pull–adhere steps (Surginus material)

Non-invasiveMethod

~1.5 mmProfile

~25 cmIncision up to

up to 15 daysWear time

Clinical description

Xkin (Foldable Skin Closure) is a non-traumatic and aesthetic alternative for wound closure, compared with thread sutures or the use of staples. Developed by Surginus, the device approximates and holds the wound edges at the skin surface by adhesion, reducing pain at closure and minimizing scarring.

Application is performed in three simple steps — align, pull, and adhere (Align – Pull – Adhere): after removing the protective films, the incision is positioned at the center of the device, then both sides are pulled to adhere the hydrocolloid to the skin. The dual hydrocolloid system provides a high adhesion force and good tensile strength (approximately 1.3 kg/10 mm), remaining on the incision even after disinfection. The gap between the hydrocolloids allows direct observation of the wound and disinfection without removing the device.

The low profile (height approximately 1.5 mm) allows application to almost any region, including spinal surgery. The device can be removed by the patient, without a hospital visit (the hydrocolloid is moistened with alcohol and peeled off along the incision line), and the recommended wear time is up to 15 days, depending on the type of procedure. The use of the hydrocolloid reduces the risk of infection. The device is applicable across a wide range of procedures: general and plastic surgery, abdominal, laparoscopic, cesarean, spinal fusion, and arthroplasties (shoulder, knee — TKR, hip — THR).

Indications

Closure of surgical skin incisions, as an alternative to sutures and staples.
General and plastic surgery; abdominal and laparoscopic surgery.
Cesarean section.
Spinal fusion (anterior and posterior).
Arthroplasties: shoulder, knee (TKR), and hip (THR).
Traumatic skin wounds and lacerations.

Xkin Foldable Skin Closure — the device (model FS2017, 174 × 57 mm), for incisions up to 17 cm (Surginus material)

Key features

Non-invasive method

Closure without sutures or staples, with minimal pain on application.

Application in 3 steps (Align–Pull–Adhere)

Fast and simple, saving operative time compared with conventional suturing.

Dual hydrocolloid

High adhesion force and tensile strength (~1.3 kg/10 mm), stable even after disinfection.

Low profile (~1.5 mm)

Applicable to almost any region, including the spine.

Removal by the patient

No hospital visit; the gap between the hydrocolloids allows direct observation and disinfection of the wound.

Reduced scarring and infection

Better scar scores vs. sutures/staples in clinical studies; the hydrocolloid reduces the risk of infection.

Technical specifications

Type: Non-invasive skin closure device with dual hydrocolloid (single-use, sterile)
Mechanism: Align – pull – adhere (Align–Pull–Adhere); adhesion on both sides of the incision
Dimensions: Width 57 mm; profile (height) approximately 1.5 mm
Models / incision length: FS2003 (~3 cm) · FS2005 (~5 cm) · FS2009 (~9 cm) · FS2013 (~13 cm) · FS2017 (~17 cm) · FS2021 (~21 cm) · FS2025 (~25 cm)
Adhesion / strength: ~313 g/10 mm adhesion; ~1.3 kg/10 mm tensile strength (dual hydrocolloid)
Wear time: Up to 15 days, depending on the procedure
Packaging: 10 pcs/box (Tyvek), sterilized, with instructions for use
Applications: General/plastic, abdominal, laparoscopic, cesarean, spinal fusion surgery, arthroplasties (shoulder, TKR, THR)

Xkin — application steps: positioning the incision at the center, removing the protective films, and adhering the hydrocolloid (Surginus material)

Clinical evidence

A selection of publications and studies that mention use of the system. Summaries are indicative; for details, consult the original source.

Comparative Evaluation of Suturing Convenience and Skin Scar of Skin Closure Methods (Suture, Foldable Skin Closure, Zip Skin Closure)

Yoo H.J., Park J.W. și colab. (Korea University Ansan Hospital) · Studiu clinic post-marketing, randomizat, de non-inferioritate, 2023 (nr. 23-HCMC-SUR)

Randomized, prospective clinical study conducted at Korea University Ansan Hospital, which compared suturing convenience and scarring for three skin closure methods: conventional suturing, Foldable Skin Closure, and Zip Skin Closure.

Closure with Foldable Skin Closure was faster (approximately 35 vs. 63 sec/cm compared with suturing) and achieved better scar scores (SBSES, VSS).

Comparison of the Efficacy and Safety of the Xkin Device Versus Staples for Closure of Surgical Wounds

Jung G., Kim B.R., Shin J.M., Huh C.-H., Lee S. · Studiu randomizat controlat, monocentric, deschis — Seoul National University Bundang Hospital

Randomized controlled trial in patients undergoing robot-assisted radical prostatectomy (RALP), comparing the Xkin device with staples for wound closure. Scarring was assessed at 2, 6, and 12 weeks (Vancouver Scar Scale — VSS and 3D skin analyzer).

At 12 weeks, the Xkin group had significantly lower VSS scores than the staple group (2.17 vs. 3.48; p=0.002), with no dehiscence or major complications.

Certifications & compliance

CE marking FDA Cleared (USA) ISO 13485 iF Design Award 2023 Red Dot Award 2022

Resources

Surginus — Foldable Skin Closure

Xkin — comparison of Foldable Skin Closure vs. sutures at 0 and 7 days postoperatively: reduced scarring and swelling (Surginus material)