7/26/2023 0 Comments Stapled wound![]() Yes, the FDA describes problems that have been reported in letters to healthcare providers, issued in March 2019 and October 2021, in which the FDA also provides several recommendations and new FDA actions regarding the safe use of surgical staplers and staples for internal use. Surgical staplers and staples for external use are used outside the body to close large wounds or surgical cuts on a patient's skin or scalp.Īdvantages of surgical staplers and staples include:Īre there problems associated with surgical staplers? Creating connections between structures (anastomoses).Cutting through and sealing organs and tissues (transection). ![]() e261-264.Surgical staplers for internal use are used to deliver staples to tissues inside the body during surgery for: A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. Staple versus suture closure of skin incisions in a pig model. The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital: adverse quality of life, excess length of stay, and extra cost. Whitehouse JD, Friedman ND, Kirkland KB, Richardson WJ, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. Hospital Infection Control Practices Advisory Committee. Guideline for prevention of surgical site infection, 1999. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. This trial was registered at under the identifier NCT01146236 (registered June 14, 2010). The following study protocol aims to guide surgeons in their choice of wound closure material by determining if there is a difference in complication rates in sutured and stapled wounds. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. Wound closure material is an afterthought for many orthopaedic surgeons. Non-infected revision surgery will also be compared to primary surgery. ![]() A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). Continuous outcome measures will be analyzed using Student's t-test. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. All data will be analyzed by a blinded statistician. An interim analysis of complications will take place after half of the patients have been recruited. All deceased patients will also be reviewed. ![]() An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. Dressings will be used to maintain blinding outcome assessors. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material.Ī parallel group randomized controlled trial with institutional review board approval will be conducted. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. ![]()
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