Track topics on Twitter Track topics that are important to you
The trial is a randomized, controlled trial. Adult patients undergoing orthopaedic surgical procedures would be randomized to one of two groups for surgical wound closure, skin sutures or skin staples. The primary outcome measures would be surgical site infection indicated by the use of oral or intravenous antibiotics for suspected wound infection and/or re-operation at the same site. Patients would be followed up as per their usual post-operative course for a total of three months in the trauma and spine population and six months in the total joint arthroplasty population. It is hypothesized that wounds closed with sutures and staples will have similar infection rates as defined by the use of antibiotics or reoperation.
To date, there is no clear consensus on the method that is best for closure of surgical wounds in orthopaedic surgery. Orthopaedic surgeons have a multitude of wound closure habits. A recent meta-analysis comparing staples to sutures in wound closure demonstrated a three-fold increase in infection in stapled wounds compared to sutured wounds. The studies used in the meta-analysis were primarily of poor methodological quality.
A large, well-designed randomized, controlled trial is needed to guide orthopedic surgeons in their choice of wound closure materials. This study would attempt to provide information on the use of sutures versus skin staples and the effect on the development of surgical site infections in adults undergoing orthopaedic procedures.
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 of participants and outcome assessors. The primary outcome measure will be infections adjudicated by a blinded data safety monitoring committee. Suspected infections will be defined by: Use of antibiotics or reoperation for infection at the operative site within three months (six months for arthroplasty subgroup) The independent review, board blinded to treatment assignment, will adjudicate suspected infections based on clinical data. A cost analysis will also be performed to compare the costs associated with wounds closed with sutures and staples from a health care institution perspective.
All data will be analyzed by a blinded epidemiologist. 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 patients. Non-infected revision surgery will also be compared to primary surgery.
It is hypothesized that wounds closed with sutures and staples will have similar infection rates as defined by the use of antibiotics or reoperation.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Surgical Wound Infection
Health Sciences Centre
Not yet recruiting
University of Manitoba
Published on BioPortfolio: 2014-07-23T21:08:45-0400
Skin closure either by sutures or staples is required after any surgical procedure of the hip. The purpose of this study is to compare the amount of drainage between patients who have had...
The objective of this randomized controlled trial is to compare wound morbidity (including disruption and infection) in surgical staples versus absorbable subcuticular suture for wound clo...
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing...
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
This study compares methods of closure for Pfannenstiel incisions commonly used during gynecological and obstetrical surgery. Patients are assigned to closure by either surgical staples o...
Traditionally, surgical procedures within the realm of both general and gynecological surgery employ the use of staples and interrupted sutures that run continuously with knot tying or subcuticular su...
Surgical site infection (SSI) is a frequent complication in dirty surgery, reaching rates of up to 40%. The incidence of SSI might be influenced by the suture used for closure of the abdominal fascia....
The appropriate choice of postoperative dressing supports effective wound healing by providing a moist wound environment and reducing the risk of surgical site infection and blistering. Wound manageme...
Deep sternal wound infection is a dreaded complication of cardiac surgery with considerable consequences in terms of mortality, morbidity and treatment costs. Multiple specific measures in the prevent...
Lower extremity joint arthroplasty procedures often require a large incision to have an adequate exposure, which subsequently leads to lengthy wounds that may contribute to long closure, anesthesia, a...
A technique of closing incisions and wounds, or of joining and connecting tissues, in which staples are used as sutures.
Materials used in closing a surgical or traumatic wound. (From Dorland, 28th ed)
Infection occurring at the site of a surgical incision.
Devices used to hold tissue structures together for repair, reconstruction or to close wounds. They may consist of adsorbable or non-adsorbable, natural or synthetic materials. They include tissue adhesives, skin tape, sutures, buttons, staples, clips, screws, etc., each designed to conform to various tissue geometries.
Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...