Skin wound closure is one of the most common medical procedures. Of the 51 million annual inpatient surgeries in the US, the majority require repair of the skin. The purpose of closing the skin is to provide external support until the wound has adequate inherent strength. If supports are removed or fail before a wound gains inherent strength, then the wound re-opens, creating a dehiscence. Dehiscence affects up to 10% of skin closures.
Inherent wound strength is only 5% of pre-injury tissue strength ten days after injury, and increases rapidly between 2-6 weeks post-injury. Most commonly, buried deep absorbable sutures and superficial non-absorbable sutures are used to provide external support until the wound has adequate inherent strength. Yet:
- non-absorbable sutures must be removed within 7 to 14 days to prevent entrapment of the sutures by wound re-epithelialization;
- providers report encountering entrapment of non-absorbable sutures at the time of their removal in 10% of cases (Akeroyd, Lear, Kitada, & Plauntz, in press); and,
- the most commonly used absorbable suture does not provide reliable support beyond 10 days in a porcine model of skin wound closure (Townsend, Lear, Robertson, & Kruzic, 2016).
To address these problems, SUTUREGARD™ Medical. has developed a range of novel, patent pending, Class I, 510(k) exempt medical devices that secure sutures using common equipment, require minimal skill, and allow non-absorbable sutures and staples to be retained in wounds for longer time periods.
We performed a pilot in vivo porcine trial showing that the SUTUREGARD™ device is:
- easily and quickly removed at 42 days post-injury;
- effective in maintaining wound closures for 42 days that are 680% stronger than wounds with supports removed at 10 days;
- well tolerated with no adverse gross or microscopic effects on the wound or skin;
- promotes skin eversion.
Townsend, K.L., Akeroyd, J., Russell, D.S, Kruzic, J.J., Robertson, B.L., & Lear, W. (In press). Comparing the tolerability of a novel wound closure device using a porcine model. Advances in Wound Care. https://tinyurl.com/y8ttwxo9
Townsend, K.L., Lear, W., Robertson, B.L, & Kruzic, J.J. (2016). Buried absorbable polyglactin 910 sutures do not result in stronger wounds in porcine full thickness skin incisions. Journal of the Mechanical Behavior of Biomedical Materials, 63, 386-389. doi:10.1016/j.jmbbm.2016.06.033
Akeroyd, J., Lear, W., Kitada, H., Plauntz, L. (2017). Nurses' experience removing superficial non-absorbable sutures from the skin: wound overgrowth of sutures complicates the procedure. Journal of Dermatology Nurses’ Association. https://tinyurl.com/y8jkxxg4