By Rebecca H. Allen, MD, MPH, Editor
This multicenter, cluster randomized trial in Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa evaluated the effect of changing sterile gloves and instruments at the time of abdominal wound closure on surgical site infection (SSI) rates among adults and children undergoing both elective and emergent surgery. The SSI rate in the intervention group among 5,789 patients was 16% compared to 18.9% in the control group of 6,768 patients (adjusted risk ratio, 0.87; 95% confidence interval, 0.79-0.95).
NIHR Global Research Health Unit on Global Surgery. Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): A pragmatic, cluster randomised-trial in seven low-income and middle-income countries. Lancet 2022;400:1767-1776.
Surgical site infections (SSIs) are infections of the skin incision or underlying organs or spaces that occur after surgery. SSI is the most common complication of surgery; various guidelines exist for its prevention. The authors of this study sought to determine whether changing into a new pair of sterile gloves and using new sterile instruments at the time of abdominal wound closure could reduce the rate of SSI, since there had been limited convincing evidence on the practice to date. The goal was to investigate this in different countries, with different surgeries and hospital types, to have a generalizable result.
The study was designed as a multicenter, international, cluster randomized controlled trial in Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa. The cluster design allowed the investigators to randomize by hospital, not by individual patient, so as not to have cross-contamination between trial groups. Eligible hospitals provided elective or emergency abdominal surgery, and patients could be adults or children undergoing surgery with clean-contaminated, contaminated, or dirty operation with at least one abdominal incision of 5 cm or greater. Patients undergoing cesarean deliveries were excluded. A minimum of four hospitals were required in each country. Training on the trial intervention was conducted only after randomization to teams from hospitals in the intervention group.
Consecutive eligible patients were identified by a member of the surgery team and patients were blinded to the process. The two components of the intervention were: 1) the operating surgeons, assistants, and scrub technicians all changed their sterile gloves, and 2) a sterile set of new instruments was used for abdominal wall closure, including needle holder, forceps, and scissors. The control was the hospital’s current practice. Other interventions to reduce SSI in either group could be used as per usual practice (for example, antibiotics if indicated, skin preparation, etc.).
Outcomes were analyzed by intention to treat, and the primary outcome was SSI up to 30 days after surgery as judged by the Centers for Disease Control and Prevention’s (CDC) definition of deep incisional or superficial incisional SSI. The outcome was assessed by trained study staff with standardized questions face to face or by telephone.
A total of 42 clusters were randomized to the current practice group (7,157 patients) and 39 to the intervention group (6,144 patients). Among the sample, 89% were adults and 11% were children, with approximately one-half male (45%) and one-half female (55%) patients. Patient characteristics were balanced between the groups (age, diabetes, human immunodeficiency virus, timing of surgery, indication for surgery, type of contamination).
There were 6,125 (46%) elective procedures and 7,176 (54%) emergency surgeries with 79% benign disease, 16% malignant, and 5% trauma. After exclusions from the primary analysis for loss to follow-up, death before outcome assessment, or consent withdrawal, there were 1,280/6,768 (18.9%) in the current practice group and 931/5,789 (16.1%) in the intervention group with SSI (adjusted risk ratio, 0.87; 95% confidence interval, 0.79-0.95). The analysis was adjusted for country and nonreferral vs. referral hospital type, as well as contamination level of surgery and urgency of surgery.
COMMENTARY
The authors of this study found that routine changing of gloves and instruments at the time of abdominal wound closure decreased the rate of SSI by 13%. The reduction was present in different countries, different hospital types, for different procedures, and in both clean-contaminated and contaminated-dirty surgery. There was a high rate of adherence in the intervention group (98.3%), which indicates the practice is easy to adopt. The study has several strengths in terms of being well-designed and applicable to many surgical settings. The authors thought the results were a significant finding that could be impactful worldwide in decreasing SSI.
SSIs are the most common hospital-associated infection in the United States. Current guidelines from the CDC for SSI prevention generally include the following:1
- Administer antimicrobial prophylaxis in accordance with evidence-based standards and guidelines;
- Before surgery, patients should shower/bathe (full body) with a soap or an antiseptic agent;
- Skin preparation in the operating room should be performed with an alcohol-based antiseptic;
- During surgery, control the blood glucose level in all patients (< 200 mg/dL);
- Maintain perioperative normothermia in all patients;
- Administer increased fraction of inspired oxygen during surgery and after extubation in the immediate postoperative period for patients with normal pulmonary function undergoing anesthesia with endotracheal intubation;
- Do not remove hair unless it will interfere with the operation, but if necessary, remove hair immediately before the operation with clippers.
Other aspects include, of course, surgical attire and hand hygiene. Our institution also has started to monitor traffic through the operating room as well, which has been found to affect SSI rates.
Although the absolute difference between the control and intervention group was small in this study, it makes sense that changing gloves and instruments would work to decrease SSI rates. In addition, the intervention is simple and likely affordable in the grand scheme of operating room costs. While this intervention could be immediately applicable to gynecologic open surgery (approximately 20% of the trial group), the obstetric population unfortunately was not studied. The authors stated this was because there already had been an international trial regarding cesarean delivery; however, this study did not address SSI.2 It was a trial regarding cesarean delivery techniques, such as single vs. double closure of the uterus.
At any rate, one could anticipate that there may be some benefit to cesarean deliveries as well, and the intervention certainly does not cause harm. Therefore, this intervention is something to consider in any multipronged approach to decreasing SSI.
REFERENCES
- Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg 2017;152:784-791.
- CORONIS collaborative group; Abalos E, Addo V, Brocklehurst P, et al. Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial. Lancet 2016;388:62-72.
