Abstract Background A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. Methods/Design A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. 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. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. Discussion Wound closure material is an afterthought for many orthopaedic surgeons. 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. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. 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. Trial Registration This trial was registered at ClinicalTrials.gov under the identifier NCT01146236 (registered June 14, 2010)

BACKGROUND: A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. METHODS/DESIGN: A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. 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. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Students t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. DISCUSSION: Wound closure material is an afterthought for many orthopaedic surgeons. 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. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. 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. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov under the identifier NCT01146236 (registered June 14, 2010).

BACKGROUND: In the spectrum of surgical decision-making, wound closure material is often an afterthought. However, the findings of a recent meta-analysis suggest that the rate of surgical site infections (SSIs) is increased by using staples to close surgical wounds. Less clear is the effect of closure material on the incidence of non-infectious wound complications.The aim of this study was to compare sutures and staples in terms of: incidence of wound complications to determine the sample size for a definitive trial comparing wound closure methods. METHODS: Eligible adult orthopaedic patients were randomized to have wounds closed with sutures or staples. Time for skin closure was recorded. Wounds were assessed for complications for six weeks. The incidence of complications was compared using Fishers exact test. Time to close and pain with removal of closure material were compared using a Students t-test. RESULTS: The total number of patients reporting a wound complication was 59 of 148 patients completing six-week followup (41%), with no differennce between sutures and staples (RR = 0.77, CI = 0.52-1.14). The time to close wounds was shorter in the staple group (mean=4.8 min, CI = 2.6-7.1) than the suture group (mean=12 min, CI = 7.9-16). Patients in the staple group (mean=3.7, CI =2.8-4.6) reported more pain with removal than suture group (mean=2.5, CI =1.6-3.4). CONCLUSIONS: This study suggests that 42% of patients report a wound complication with no difference between sutures and staples. It was demonstrated that suturing skin requires more time and staples are more painful to remove. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT01146236 (registered June 14, 2010).

Abstract Background In the spectrum of surgical decision-making, wound closure material is often an afterthought. However, the findings of a recent meta-analysis suggest that the rate of surgical site infections (SSIs) is increased by using staples to close surgical wounds. Less clear is the effect of closure material on the incidence of non-infectious wound complications. The aim of this study was to compare sutures and staples in terms of: incidence of wound complications to determine the sample size for a definitive trial comparing wound closure methods. Methods Eligible adult orthopaedic patients were randomized to have wounds closed with sutures or staples. Time for skin closure was recorded. Wounds were assessed for complications for six weeks. The incidence of complications was compared using Fisher’s exact test. Time to close and pain with removal of closure material were compared using a Student’s t-test. Results The total number of patients reporting a wound complication was 59 of 148 patients completing six-week followup (41%), with no differennce between sutures and staples (RR = 0.77, CI = 0.52–1.14). The time to close wounds was shorter in the staple group (mean=4.8 min, CI = 2.6–7.1) than the suture group (mean=12 min, CI = 7.9–16). Patients in the staple group (mean=3.7, CI =2.8–4.6) reported more pain with removal than suture group (mean=2.5, CI =1.6–3.4). Conclusions This study suggests that 42% of patients report a wound complication with no difference between sutures and staples. It was demonstrated that suturing skin requires more time and staples are more painful to remove. Trial registration Clinicaltrials.gov identifier NCT01146236 (registered June 14, 2010)