Dataset Information

Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61 additional skin closure staples and vessel ligation clips.

ABSTRACT:

Purpose

Metallic skin closure staples and vessel ligation clips should be tested at 3-Tesla to characterize MRI issues in order to ensure patient safety. Therefore, metallic surgical implants were assessed at 3-Tesla for magnetic field interactions, MRI-related heating, and artifacts.

Methods

A skin closure staple (Visistat Skin Stapler, staple, Polytetrafluoroethylene, PTFE, coated 316L/316LVM stainless steel; Teleflex Medical, Durham, NC) and a vessel ligation clip (Hemoclip Traditional, stainless steel; Teleflex Medical, Durham, NC) that represented the largest metallic sizes made from materials with the highest magnetic susceptibilities (i.e., based on material information) among 61 other surgical implants (52 metallic implants, 9 nonmetallic implants) underwent evaluation for magnetic field interactions, MRI-related heating, and artifacts using standardized techniques. MRI-related heating was assessed by placing each implant in a gelled-saline-filled phantom with MRI performed using a transmit/receive RF body coil at an MR system reported, whole body averaged SAR of 2.9-W/kg for 15-min. Artifacts were characterized using T1-weighted, SE and GRE pulse sequences.

Results

Each surgical implant showed minor magnetic field interactions (20- and 27-degrees, which is acceptable from a safety consideration). Heating was not substantial (highest temperature change, ? 1.6°C). Artifacts may create issues if the area of interest is in the same area or close to the respective surgical implant.

Conclusions

The results demonstrated that it would be acceptable for patients with these metallic surgical implants to undergo MRI at 3-Tesla or less. Because of the materials and dimensions of the surgical implants that underwent testing, these findings pertain to 61 additional similar implants.

SUBMITTER: Gill A

PROVIDER: S-EPMC3275510 | biostudies-literature | 2012 Jan

REPOSITORIES: biostudies-literature

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Publications

Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61 additional skin closure staples and vessel ligation clips.

Gill Amreeta A Shellock Frank G FG

Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance 20120109

<h4>Purpose</h4>Metallic skin closure staples and vessel ligation clips should be tested at 3-Tesla to characterize MRI issues in order to ensure patient safety. Therefore, metallic surgical implants were assessed at 3-Tesla for magnetic field interactions, MRI-related heating, and artifacts.<h4>Methods</h4>A skin closure staple (Visistat Skin Stapler, staple, Polytetrafluoroethylene, PTFE, coated 316L/316LVM stainless steel; Teleflex Medical, Durham, NC) and a vessel ligation clip (Hemoclip Tra ...[more]

PMID: 22230200

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Project description:ObjectiveTo compare the clinical outcomes of staples versus sutures in wound closure after orthopaedic surgery.DesignMeta-analysis.Data sourcesMedline, CINAHL, AMED, Embase, Scopus, and the Cochrane Library databases were searched, in addition to the grey literature, in all languages from 1950 to September 2009. Additional studies were identified from cited references. Selection criteria Two authors independently assessed papers for eligibility. Included studies were randomised and non-randomised controlled trials that compared the use of staples with suture material for wound closure after orthopaedic surgery procedures. All studies were included, and publications were not excluded because of poor methodological quality. Review methods Two authors independently reviewed studies for methodological quality and extracted data from each paper. Final data for analysis were collated through consensus. The primary outcome measure was the assessment of superficial wound infection after wound closure with staples compared with sutures. Relative risk and mean difference with 95% confidence intervals were calculated and pooled with a random effects model. Heterogeneity was assessed with I(2) and chi(2) statistical test.ResultsSix papers, which included 683 wounds, were identified; 332 patients underwent suture closure and 351 staple closure. The risk of developing a superficial wound infection after orthopaedic procedures was over three times greater after staple closure than suture closure (relative risk 3.83, 95% confidence interval 1.38 to 10.68; P=0.01). On subgroup analysis of hip surgery alone, the risk of developing a wound infection was four times greater after staple closure than suture closure (4.79, 1.24 to 18.47; P=0.02). There was no significant difference between sutures and staples in the development of inflammation, discharge, dehiscence, necrosis, and allergic reaction. The included studies had several major methodological limitations, including the recruitment of small, underpowered cohorts, poorly randomising patients, and not blinding assessors to the allocated methods of wound closure. Only one study had acceptable methodological quality.ConclusionsAfter orthopaedic surgery, there is a significantly higher risk of developing a wound infection when the wound is closed with staples rather than sutures. This risk is specifically greater in patients who undergo hip surgery. The use of staples for closing hip or knee surgery wounds after orthopaedic procedures cannot be recommended, though the evidence comes from studies with substantial methodological limitations. Though we advise orthopaedic surgeons to reconsider their use of staples for wound closure, definitive randomised trials are still needed to assess this research question.

Project description: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).

Dataset Information

Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61 additional skin closure staples and vessel ligation clips.

Purpose

Methods

Results

Conclusions

Publications

Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61 additional skin closure staples and vessel ligation clips.

Similar Datasets

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