Evidence-based clinical uses for surgical incisions, lacerations, trauma, and dermatologic procedures
SYLKE Adhesive Wound Closure is an FDA Class I sterile medical device designed for primary closure and coverage of clean, simple lacerations, cuts, puncture wounds, and post-surgical incisions. Below are the seven core clinical applications supported by the product's indications and clinical evidence.
Indication: SYLKE is designed to close and cover post-surgical skin incisions, including those with subcutaneous or dermal sutures, assisting in bringing together skin edges and protecting the wound during initial healing.
Clinical Applications:
Key Advantages:
SYLKE's woven silk fibroin backing provides structural support while the pressure-sensitive adhesive conforms to the contours of healing tissue. The strip remains flexible during the 14-day healing window, accommodating tissue swelling and movement without compromising adhesion or causing tissue stripping on removal.
Clinical evidence shows SYLKE outperforms both Steri-Strips and cyanoacrylate adhesives in 14-day holding power and minimal adverse reactions, making it ideal for post-operative incision protection.
Indication: SYLKE is indicated for topical closure of thoroughly cleansed simple lacerations, cuts, and puncture wounds, assisting in bringing together skin edges during the initial healing phase.
Clinical Applications:
Application Advantage: SYLKE can be applied in clinical or home settings without special equipment. The device is single-use, sterile, and requires only thorough wound cleansing and drying before application — making it practical for urgent care, emergency, and home care scenarios.
Contraindications to Monitor:
SYLKE transforms laceration management by eliminating the need for sutures in appropriate wounds. A simple 7-step process — cleanse, dry, apply, remove liner, trim, press, secure — delivers immediate, reliable closure.
The adhesive strength is sufficient for simple wounds, and the water-resistant design allows patients to resume normal activities, including bathing, during the 14-day wear period. Early removal (before 14 days) may cause skin irritation or stripping, so proper patient education is essential.
Indication: SYLKE is suitable for post-Mohs surgical wound closure on the face and other cosmetically sensitive areas, providing adjunctive closure over sutures or as standalone approximation for minor defects.
Clinical Context:
Key Advantages in Dermatologic Surgery:
Mohs micrographic surgery requires meticulous tissue approximation and protection during the critical first 14 days of healing. SYLKE supports this goal without the irritation and contact dermatitis risk associated with cyanoacrylates.
A peer-reviewed study in Plastic and Reconstructive Surgery comparing SYLKE to 3M™ Steri-Strips™ demonstrated superior 14-day holding power and significantly lower erythema rates (0% vs 20.8%), making SYLKE the evidence-backed choice for high-visibility facial surgery sites.
Indication: SYLKE is designed for post-operative incision care following major orthopedic procedures, providing protection and closure support for surgical sites where wound integrity and infection prevention are critical.
Common Orthopedic Applications:
Why Orthopedic Surgeons Choose SYLKE:
Orthopedic surgery creates high-demand incision environments: movement, swelling, moisture from perspiration, and extended healing timelines. SYLKE's pressure-sensitive adhesive and water-resistant design withstand these challenges while maintaining structural support.
Clinicians report that SYLKE can remain in place during standard post-operative protocols including physical therapy, normal bathing, and dynamic range-of-motion exercises — making it a practical choice for active orthopedic patients.
Indication: SYLKE is ideal for pediatric laceration repair and surgical closure, offering a non-traumatic, hypoallergenic alternative to traditional sutures or cyanoacrylate adhesives.
Pediatric Clinical Applications:
Why SYLKE is Preferred for Pediatric Patients:
Pediatric wound closure demands a gentler approach. SYLKE eliminates multiple pain points: no chemical irritation from cyanoacrylates, no suture removal discomfort, and no anxiety-inducing dressing changes.
Parents appreciate the simplicity: a one-time application that stays in place for up to 14 days, tolerates normal play and bathing, and peels off gently without causing additional trauma or distress.
Indication: SYLKE can be used alone or with sutures, supporting and assisting in bringing together skin edges during initial healing.
Clinical Use: Many surgeons layer SYLKE over dermal or subcuticular sutures to provide additional skin edge approximation, reduce tension on the suture line, and protect the incision from external contamination. This combination approach is particularly valuable in:
Practical Advantages of Adjunctive Use:
Indication: SYLKE can be applied by consumers in home settings for thoroughly cleansed simple lacerations, cuts, puncture wounds, and post-operative incisions, making it accessible for minor wounds without professional healthcare involvement.
Consumer Applications:
Consumer Education Requirements: For safe home use, patients must understand:
SYLKE democratizes wound care. A simple minor laceration no longer requires an ER visit or urgent care appointment. With clear instructions and an understanding of when professional help is needed, patients can confidently close and protect clean, simple wounds at home.
The sterile, single-use packaging and straightforward 7-step application process make SYLKE an ideal addition to first-aid kits, travel supplies, and athletic trainer bags.
From IFU (Instructions for Use) — Follow these steps for optimal adhesion and wear
SYLKE is designed to remain in place for up to 14 days. Early removal may cause skin irritation or stripping.
After removal, the wound should be well-closed and in the final stages of healing. Continue gentle hygiene and sun protection (especially for facial wounds). Light scar massage and silicone-based scar treatments may be considered to optimize long-term scar appearance.
If you experience unexpected pain, redness, swelling, or discharge during or after removal, contact a healthcare provider for evaluation.
SYLKE's safety and efficacy are supported by peer-reviewed research comparing it directly to competing wound closure products.
Key Findings: In a randomized controlled trial of 25 patients, SYLKE showed superior biocompatibility compared to the cyanoacrylate-based Dermabond Prineo.
Conclusion: SYLKE's hypoallergenic silk fibroin formulation demonstrates significantly lower rates of contact dermatitis and discomfort compared to cyanoacrylate adhesives, making it the safer choice for sensitive skin and extended wear.
Key Findings: In a 50-patient randomized controlled trial published in Plastic and Reconstructive Surgery, SYLKE demonstrated superior adhesive performance and biocompatibility compared to traditional Steri-Strips.
Conclusion: SYLKE's water-resistant construction and superior adhesive longevity make it more effective than Steri-Strips for the full 14-day healing window, particularly in high-moisture or high-mobility environments.
A comprehensive review of incisional wound closure techniques and materials supports the use of advanced adhesive-based closure systems for primary skin closure and post-operative incision protection. SYLKE's woven silk mesh backing and pressure-sensitive adhesive align with evidence-based best practices for wound closure.
A dedicated study examining allergic contact dermatitis risk from wound closure materials demonstrated that silk fibroin (the primary component of SYLKE) is hypoallergenic and does not elicit delayed-type hypersensitivity reactions common with synthetic adhesives or cyanoacrylate-based products.
Research on silk fibroin as a wound dressing material demonstrates that its natural protein structure supports biocompatibility, reduces inflammatory responses, and promotes optimal tissue remodeling during the healing process. These properties explain SYLKE's effectiveness in minimizing scarring and adverse tissue reactions.
SYLKE is available in three sizes. Select the size that best fits your wound length and location.
| Size | Dimensions | Best Uses | Typical Applications |
|---|---|---|---|
| Large | 32 cm × 2.5 cm | Extended incisions, body contouring, large lacerations | Abdominoplasty, thigh/hip lift, extensive trauma |
| Medium | 24 cm × 3.4 cm | Standard surgical incisions, moderate lacerations | General surgery, orthopedic, dermatologic procedures |
| Small | 16 cm × 2.5 cm | Facial closures, pediatric wounds, small lacerations | Post-Mohs, small cuts, pediatric trauma, biopsy sites |
SYLKE can be trimmed to any length with clean scissors, so it's better to choose a larger size if unsure. A 5-10 cm wound might use a 16 cm strip (trimmed), while a 15-20 cm incision would use the 24 cm or 32 cm size. Ensure at least 1 cm of adhesive extends beyond the wound edge on both sides for optimal holding power.
SYLKE is not appropriate for all wound types. Review these contraindications and warnings before application.
Answers to help you understand SYLKE's indications, application, and care.
No. SYLKE is made from silk fibroin derived from silkworms, not spiders. Silk fibroin is a natural protein harvested from silkworm cocoons and woven into mesh strips. It is biocompatible, hypoallergenic, and has been used in medical applications for decades.
SYLKE consists of a sterile, woven silk fibroin mesh backing with a pressure-sensitive adhesive on one side. It contains no cyanoacrylates, no synthetic plastics, and no harsh chemicals. The entire product is designed for biocompatibility and minimal inflammatory response.
Yes. SYLKE is water-resistant and can tolerate normal bathing and showering. However, avoid prolonged immersion (e.g., extended swimming sessions or hot tubs). The 14-day wear window is designed to accommodate normal daily activities including bathing, but not submersion in water for extended periods.
Steri-Strips are latex-free, acrylic adhesive strips with a rayon backing. They typically degrade after 7-10 days in moist environments. SYLKE has a woven silk fibroin backing with a superior pressure-sensitive adhesive that maintains 14-day holding power even in high-moisture conditions. Clinical evidence shows SYLKE outperforms Steri-Strips in 14-day adhesion and reduces erythema risk.
No. SYLKE contains zero cyanoacrylates. It is a pressure-sensitive adhesive product, meaning the adhesive becomes active only when pressure is applied. Dermabond and Dermabond Prineo are cyanoacrylate-based adhesives that cure chemically. SYLKE's cyanoacrylate-free design significantly reduces allergic contact dermatitis risk (0% in trials vs. 52% for Dermabond Prineo).
SYLKE is designed to remain in place for up to 14 days under normal conditions. After 14 days, the adhesive naturally degrades and the strip becomes easier to remove. Removing SYLKE before 14 days may cause skin irritation or stripping.
No. SYLKE is contraindicated for infected wounds. Signs of infection include pus, pain, warmth, redness, swelling, and fever. If your wound shows these signs, do not apply SYLKE. Instead, contact a healthcare provider for evaluation and appropriate treatment.
A clean, simple wound is one that does not involve deep structures (fascia, muscle, bone), has well-approximated edges, is free from dirt and debris, and shows no signs of infection. If you have any doubt, consult a healthcare provider. High-tension wounds or those with irregular edges may require professional evaluation and potentially sutures in addition to SYLKE.
Yes. SYLKE is hypoallergenic. Silk fibroin is a natural protein that does not elicit allergic contact dermatitis reactions. Clinical studies show 0% allergic contact dermatitis with SYLKE compared to 52% with cyanoacrylate products, making it ideal for sensitive skin and patients with contact dermatitis history.
SYLKE Adhesive Wound Closure is an FDA Class I sterile medical device indicated for topical closure and coverage of thoroughly cleansed simple lacerations, cuts, puncture wounds, and post-surgical skin incisions (including those with subcutaneous or dermal sutures). It assists in bringing together skin edges and protecting wounds during initial healing.
This information is provided for educational purposes and does not constitute medical advice. All applications described here are within SYLKE's FDA-cleared indications. Individual clinical decisions must be made in consultation with a qualified healthcare provider, taking into account the patient's medical history, wound characteristics, and applicable clinical protocols.
For current FDA clearance status, complete product information, and detailed Instructions for Use, please consult the product labeling or contact Sunspot Medical Group directly.
If you have questions about whether SYLKE is appropriate for your specific wound, please contact a healthcare provider or our clinical support team.
Contact Sunspot Medical Group for clinical training, product orders, or evidence-based consultation on SYLKE applications.