Ann Thorac Surg 2006;82:1494-1496
© 2006 The Society of Thoracic Surgeons
New Technology
A Wire-Cutting Clamp Designed to Reduce Complications During Sternotomy Closure
Daniel H. Drake, MD*
Department of Surgery, Section of Cardiothoracic Surgery, Munson Medical Center, Traverse City, Michigan
Accepted for publication March 28, 2006.
* Address correspondence to Dr Drake, Munson Professional Building, 1221 Sixth St, Suite 202, Traverse City, MI 49684 (Email: tcbulldog{at}charter.net).
| Dr Drake discloses that he has a financial relationship with Thompson Surgical Instruments Inc.
|
 |
Abstract
|
|---|
PURPOSE: Sternal wire placement frequently results in glove disruption, wound contamination and personnel skin puncture. The described cutting clamp was developed to simplify sternotomy closure and reduce complications.
DESCRIPTION: Informed consent was obtained from 103 patients who underwent a variety of common cardiac surgical procedures. In each instance, once the cardiac portion of the procedure was completed, the median sternotomy was closed using standard sternal wires and the described cutting clamps. A single set of clamps was repeatedly re-sterilized and used for all cases.
EVALUATION: There were no incidents of unintentional clamp release, glove disruption or personnel skin punctures from the wire. None of the patients had clinically evident sternal wound infections or nonunion. There were no deaths. The functional attributes of the clamps remained constant throughout the study, and no significant wear was detected on the carbide inserts or other components of the clamps.
CONCLUSIONS: The sternal wire-cutting clamp simplifies sternal closure and should reduce complications.
Sternal closure is routinely accomplished using stainless steel wire. Previously described wire clamps have not included a cutting mechanism within the device [1, 2]. A clamp that simultaneously cuts and clamps the sternal wire was developed to simplify wound closure and reduce complications. The device is described and a retrospective patient analysis is presented.
|
Technology and Technique
|
|---|
Patients and Methods
The sternal wire-cutting clamp (Fig 1) is a 16-cm long reusable surgical stainless steel single-hinged locking clamp with carbide inserts that simultaneously grasps and cuts the wire typically used for sternal closure (Thompson Surgical Instruments Inc, Traverse City, MI). The clamp firmly grasps the wire so that additional manuevers, such as wrapping the wire around the clamp, are unnecessary (Fig 2). The cutting mechanism has been designed to eliminate wire end protrusion, thereby reducing the risk of operator skin puncture. All exposed edges have been carefully milled to minimize the risk of glove disruption that is common with conventional hemostat tips. The overall size and balance of the clamp facilitates wire manipulation for sternal approximation (Fig 3). The simple ratchet mechanism was designed to easily release the wire from a remote location on the clamp thereby minimizing the risk of operating room personnel injury (Fig 4). Finger guides and labeling designate appropriate hand and wire positioning. The cutting clamp will simultaneously grasp and cut all sternal wires commonly used in the United States. This study was approved on March 17, 2006 by the Munson Medical Center Institutional Review Board.
View larger version (13K):
[in this window]
[in a new window]
|
Fig 1. The sternal wire-cutting clamp is a balanced, 16-cm long, reusable surgical stainless steel single-hinged locking clamp with carbide inserts that simultaneously grasp and cut wire typically used for sternal closure. All exposed edges have been milled to minimize the risk of glove disruption. Finger guides and labeling designate appropriate hand and wire positioning.
|
|
View larger version (54K):
[in this window]
[in a new window]
|
Fig 2. The sternal wire is firmly grasped by the clamp and the cut end of the wire does not protrude. The label indicates the side of the clamp that cuts the wire.
|
|
View larger version (15K):
[in this window]
[in a new window]
|
Fig 4. The locking mechanism allows release and disposal of the wire remnants from a location on the clamp remote from the wire itself. This further reduces the risk of injury for operating room personnel.
|
|
After completing the appropriate preoperative evaluation and obtaining informed consent, 103 patients underwent a variety of cardiac surgical procedures through a median sternotomy. In each instance, once the cardiac portion of the procedure was completed, the median sternotomy was closed with at least 6 sternal wires. The number 5 surgical stainless steel wires were preloaded with a standard heavy needle holder applied to the needle and a cutting clamp on the other end. After appropriate sternal wire placement, the wire was simultaneosly grasped and divided between the needle and the sternum with a second cutting clamp. The needle and wire remnant were passed off of the field. Successive pairs of clamps with the interposed wire were used to approximate the sternum and initiate wire twisting. The excess wire was removed and the remaining wire was tightened with a heavy needle holder. The soft tissues were closed and dressings applied.
|
Clinical Experience
|
|---|
The cutting clamps were used for sternal closure in 103 patients after routine cardiac surgical procedures. Sixty-two patients (60%) underwent coronary artery bypass grafting alone. Twenty-five (24%) underwent valve repair or replacement. Fourteen (14%) underwent combined valve and bypass grafting procedures. Two (2%) underwent ascending aortic reconstruction. Four (4%) of these patients had undergone at least one previous median sternotomy. At 30 days after surgery there were no deaths, strokes, or major organ system complications. There were no incidents of unintentional clamp release, glove disruption or personnel skin punctures from the wire ends. None of the patients had clinically significant wound infections of any kind and none had clinically evident sternal nonunion.
A single set of clamps with the same carbide inserts was repeatedly re-sterilized and used for all 103 patients. The functional attributes of the clamp remained constant throughout the study and no significant wear was detected on close inspection of the carbide inserts or other components of the clamps. This finding was consistent with the prior bench trial in which a randomly selected clamp was submitted to over 2,000 wire cuts and, on subsequent inspection, no significant wear was demonstrated.
|
Comment
|
|---|
The median sternotomy remains the mainstay of major cardiac surgical incisions. The sternotomy provides excellent exposure for most procedures and is associated with low wound complication rates. However, when complications arise they are often severe. Sternal closure is frequently associated with glove dysruption. Published reports indicate that greater than one third of the cardiac surgeons' gloves are perforated after sternal closure [3]. The specialty of cardiac surgery has been cited for increased risk of bloodborne pathogen transmission to the surgeon during sternal closure [4]. Bloodborne pathogen transmission from the cardiac surgeon to the patient has also been well documented [5, 6]. Deep sternal wound infection dramatically increases perioperative morbidity, mortality, and cost [7, 8]. Long-term survival is substantially decreased [9]. Even if wound infection or bloodborne pathogen transmission does not occur, the personal impact of potential exposure can be substantial [10]. Continued efforts to reduce wound contamination and personnel injury are imperative. Instrument design plays a major role in risk reduction.
The described wire-cutting clamp was designed to simplify sternal closure. Unlike previous designs, this device simultaneously cuts and clamps the sternal wire. There were no wound or wire-related complications during this trial. The sternal wire-cutting clamp simplifies sternal closure, saves time, and should reduce complications.
|
Disclosures and Freedom of Investigation
|
|---|
The clamps were designed by the author in conjunction with Thompson Surgical Instruments, Inc. There was no industry funding for this study. The clamps were loaned to Munson Medical Center for purposes of this study. The author had full control of the design of the study, methods used, outcome measurements, analysis of data, and production of the written report.
|
Disclaimer
|
|---|
The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.
|
References
|
|---|
- Korompai F, Hayward R, Guinn G. Clamp for wire closure of sternum Ann Thorac Surg 1976;21:249.[Abstract]
- Rubio P. Wire holder: a new adjunct for sternal closure J Thorac Cardiovasc Surg 1977;73(3):449-450.[Abstract]
- Hosie K, Dunning J, Bailey J, Firman R. Glove perforation during sternotomy closure Lancet 1988;2:1500.[Medline]
- Johnston B, Conly J. Nosocomial transmission of bloodborne viruses from infected health care workers to patients Can J Infect Dis Med Microbiol 2003;14:192.
- Esteban J, Gomez J, Martell M, et al. Transmission of hepatitis C virus by a cardiac surgeon NEJM 1996;334:555-560.[Abstract/Free Full Text]
- Incident control teams and othersLessons from two linked clusters of acute hepatitis B in cardiothoracic surgery patients. Commun Dis Rep CDR Rev 1996;6:R119-R125.[Medline]
- Stahle E, Tammelin A, Bergstrom R, et al. Sternal wound complications—incidence, microbiology and risk factors Eur J Cardiothorac Surg 1997;11:1146-1153.[Abstract]
- Mossad S, Serkey J, Longworth D, et al. Coagulase-negative staphylococcal sternal wound infections after open heart operations Ann Thorac Surg 1997;63:395-401.[Abstract/Free Full Text]
- Toumpoulis I, Anagnostopoulos C, DeRose J, et al. Impact of deep sternal wound infection on long-term survival after coronary bypass grafting Chest 2005;127:464-471.[Abstract/Free Full Text]
- Louie T. Occupational Hazards N Engl J Med 2005;353:757-758.[Free Full Text]
Top
Abstract
Introduction
