The Effect of the Care Bundle to be Applied to Obesity Surgery Patients on Surgical Site Infection and Patient Comfort

Bariatric Surgery Candidate Clinical Trial

Official title:

The Effect of Care Bundle Applied to Patients Undergoing Bariatric Surgery on Surgical Site ınfection and Comfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930639
• Other study ID #: 2022-07-22/30
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: October 2023

Study information

• Verified date: June 2023
• Source: Malatya Turgut Ozal University
• Contact: research assistant
• Phone: +90 05534491539
• Email: hatice.cakir[@]ozal.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the most effective treatment methods of obesity is surgery. Bariatric surgery is classified as a clean-contaminated wound. The expected benefit from surgery is weight loss. However, surgical site infection is among the complications. Although many methods are applied to reduce these rates, it is not very possible to reduce them to zero. It is predicted that the incidence of infection will decrease with surgical care packages created from the combination of evidence-based interventions applied.

This study was a randomized controlled trial designed to determine the effect of the Surgical Site Infection (SSI) prevention package on SSI and patient comfort in patients undergoing bariatric surgery.

The questions to be answered by the research are;

• What is the effect of the care package applied to patients undergoing bariatric surgery on surgical site infection?

• What is the effect of the care package applied to patients undergoing bariatric surgery on comfort? .Patients aged 18 and over who have had bariatric surgery (sleeve gastrectomy) will be taken from a private hospital in Kayseri. All surgeries will be performed by the same surgeon. The care package (identification of risk factors, antibiotic prophylaxis, normothermia, normoglycemia and patient education) prepared for the experimental group will be applied. On the 30th day, the patient is called by phone and the surgical site infection findings are questioned.

Description:

Surgical Site Infection (SSI) was identified by the Center for Disease Control and Prevention (CDC) as a secondary surgical infection within 30 days after surgery. 2017 Health Service Related Infections Surveillance Network report in Turkey, according to the overall SSI rate is 0.72. A study in the literature found the incidence of as 22.2% after abdominal surgery. SSI has been shown to affect one in about every five patients undergoing abdominal surgery and has an incidence of approximately 20%-25% ' associated with contamination. In a comprehensive study conducted in Turkey, it was determined that SSI was seen in the third row after upper gastrointestinal (GIS) surgery and 47.06% of the patients were diagnosed with SSI after discharge.

In a retrospective study investigating the factors that predispose to SSI in general surgery; American Society of Anesthesiologists (ASA) score, wound classification (clean-contaminated, contaminated and dirty/infected wounds), operation history, prolongation of operation time, hypoalbuminemia, history of Chronic Obstructive Pulmonary Disease were defined as major risk factors for the development of SSI. Preoperative low hemoglobin, history of congestive heart failure, excessive alcohol use, surgery at the previous incision site, presence of existing infection, long preoperative and postoperative hospital stay, obesity, steroid use, preoperative epilation, operative data (surgeon's experience, incision device) , drain use, prosthetic mesh use, intraoperative blood transfusion) are other risk factors that increase the risk of SSI.It is suggested that by determining risk factors to reduce the incidence of SSI, it reduces hospital stay and health spending and decreases morbidity and mortality rates.

Bariatric surgery is an effective and widely used treatment for obese patients. The expected benefit from this surgical treatment is weight loss. In addition, this surgery can lead to the development of complications that have significant effects on morbidity and mortality.The use of antimicrobial prophylaxis for organisms causing SSI is important in bariatric surgery. The purpose of antibiotic prophylaxis is to reduce the bacterial load to a level that can be controlled by host defenses.

İnadvertent Perioperative Hypothermia (IPH) (body temperature below 36 °C) is a risk factor for the development of SSI. In a study investigating the effect of hypothermia on SSI in gastroenterological surgery, hypothermia was found to be associated with a higher incidence of organ/space SSI. IPH can cause prolonged hospital stay, cardiac morbidity, increased blood loss, and many complications such as tissue hypoxia and SSI due to neutrophil dysfunction.The CDC recommends maintaining perioperative normothermia to prevent SSI, and the recommendation is considered as the evidence level category IA. The current guidelines propose to use effective heating methods to maintain normothermia in the perioperative period and to measure the patient's body temperature.

Hyperglycemia is another independent risk factor for SSI. In a retrospective study, it was shown that serum glucose level higher than 110 mg/dL is associated with a gradual increase in post-surgical infection rates, and performing glycemic control in the first 48 hours after surgery reduces SSIs. CDC recommended performing perioperative glycemic control in patients with and without diabetes and use blood glucose target levels below 200 mg/dL.( Category IA - strong recommendation; high to medium quality evidence ). Hyperglycemia is a preventable variable to reduce the incidence of SSI.

Another important factor for SSI prevention is patient education. For this reason, the patient and his family should be trained to prevent proper wound care and SSI. However, the benefit of existing patient education materials is uncertain, and a limited number of patient training materials for SSI prevention were found for patients with bariatric surgery.

The concept of "Care Package" has been brought to the agenda by the American Institute for Healthcare Improvement (IHI) in order to achieve more optimal results by applying the interventions with positive results individually in line with evidence-based approaches. IHI has the criteria for inclusion of an element in the care package; It has identified it as consensus and high acceptance, providing solid evidence for clinical change, with little or no discussion of its activities. Maintenance packages with few and simple items have been determined to have better compliance rates. In a systematic review and meta-analysis study, it was reported that the use of SSI measure packages was estimated to prevent 60% of the incidence of SSI. SSI is a complex problem affected by many factors. SSI reduction strategies are multimodal and take place in a number of environments under the supervision of a large number of providers. Ensuring a high level of compliance with these risk reduction strategies is crucial to the success of SSI mitigation efforts.

In different studies, in which multidisciplinary care packages aimed at preventing SSI were applied, significant reductions were achieved in the long term and the use and development of care packages was recommended. Packages can improve the quality of surgical care for patients by providing a harmonious environment and standardization, effectively reducing the risk of SSI. This improvement in the quality of care may increase the comfort level of patients.The concept of comfort in the nursing discipline is based on meeting the needs and is accepted as a part of quality care.

This study is planned to determine the effect of the SSI prevention package on SSI and patient comfort in patients undergoing bariatric surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 years and over

• undergoing sleeve gastrectomy surgery

• who volunteered to participate in the study

Exclusion Criteria:

• under 18 years old

• Surgeries other than sleeve gastrectomy

• not willing to participate in the study

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Infections
• Surgical Wound Infection

Intervention

Other:
• Surgical Site Infection (SSI) prevention package
Care package components to be applied to the intervention group; identification of risk factors, antibiotic prophylaxis, normothermia, normoglycemia and patient education. Risk factors will be evaluated when the patient is admitted to the clinic. Antibiotics (imipenem + cilastatin sodium) routinely administered by the institution before surgery will be administered in both groups. Passive heating methods will be used to maintain body temperature for the first 24 hours after surgery. In the perioperative period, the blood glucose level will be kept below 200mg/dl for 48 hours. Before the operation and before discharge, the patient is educated about infection prevention measures.

Locations

Country	Name	City	State
Turkey	Hatice ÇAKIR	Malatya
Turkey	Meryem Yilmaz	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Malatya Turgut Ozal University

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

Aga E, Keinan-Boker L, Eithan A, Mais T, Rabinovich A, Nassar F. Surgical site infections after abdominal surgery: incidence and risk factors. A prospective cohort study. Infect Dis (Lond). 2015;47(11):761-7. doi: 10.3109/23744235.2015.1055587. Epub 2015 Jun 26. — View Citation

Alkaaki A, Al-Radi OO, Khoja A, Alnawawi A, Alnawawi A, Maghrabi A, Altaf A, Aljiffry M. Surgical site infection following abdominal surgery: a prospective cohort study. Can J Surg. 2019 Apr 1;62(2):111-117. doi: 10.1503/cjs.004818. — View Citation

Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74. doi: 10.1016/j.jamcollsurg.2016.10.029. Epub 2016 Nov 30. No abstract available. — View Citation

Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904. Erratum In: JAMA Surg. 2017 Aug 1;152(8):803. — View Citation

Carvalho RLR, Campos CC, Franco LMC, Rocha AM, Ercole FF. Incidence and risk factors for surgical site infection in general surgeries. Rev Lat Am Enfermagem. 2017 Dec 4;25:e2848. doi: 10.1590/1518-8345.1502.2848. — View Citation

Chopra T, Zhao JJ, Alangaden G, Wood MH, Kaye KS. Preventing surgical site infections after bariatric surgery: value of perioperative antibiotic regimens. Expert Rev Pharmacoecon Outcomes Res. 2010 Jun;10(3):317-28. doi: 10.1586/erp.10.26. — View Citation

Haridas M, Malangoni MA. Predictive factors for surgical site infection in general surgery. Surgery. 2008 Oct;144(4):496-501; discussion 501-3. doi: 10.1016/j.surg.2008.06.001. — View Citation

Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available. Erratum In: Am J Infect Control. 2008 Nov;36(9):655. — View Citation

Isik O, Kaya E, Dundar HZ, Sarkut P. Surgical Site Infection: Re-assessment of the Risk Factors. Chirurgia (Bucur). 2015 Sep-Oct;110(5):457-61. — View Citation

Tsuchida T, Takesue Y, Ichiki K, Uede T, Nakajima K, Ikeuchi H, Uchino M. Influence of Peri-Operative Hypothermia on Surgical Site Infection in Prolonged Gastroenterological Surgery. Surg Infect (Larchmt). 2016 Oct;17(5):570-6. doi: 10.1089/sur.2015.182. Epub 2016 Mar 30. — View Citation

Wang Z, Chen J, Wang P, Jie Z, Jin W, Wang G, Li J, Ren J. Surgical Site Infection After Gastrointestinal Surgery in China: A Multicenter Prospective Study. J Surg Res. 2019 Aug;240:206-218. doi: 10.1016/j.jss.2019.03.017. Epub 2019 Apr 12. — View Citation

Weiser MR, Gonen M, Usiak S, Pottinger T, Samedy P, Patel D, Seo S, Smith JJ, Guillem JG, Temple L, Nash GM, Paty PB, Baldwin-Medsker A, Cheavers CE, Eagan J, Garcia-Aguilar J; Memorial Sloan Kettering Multidisciplinary Surgical-Site Infection Reduction Team. Effectiveness of a multidisciplinary patient care bundle for reducing surgical-site infections. Br J Surg. 2018 Nov;105(12):1680-1687. doi: 10.1002/bjs.10896. Epub 2018 Jul 4. — View Citation

Zellmer C, Zimdars P, Parker S, Safdar N. Evaluating the usefulness of patient education materials on surgical site infection: a systematic assessment. Am J Infect Control. 2015 Feb;43(2):167-8. doi: 10.1016/j.ajic.2014.10.020. Epub 2014 Dec 23. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery Site Infection	The Centers for Disease Control and Prevention (CDC) defined SSI as an infection secondary to surgery in the superficial, deep or organ cavity within 30 days of surgery. On the 7th day after surgery, the wound will be observed for infection while the stitches are removed. In the presence of symptoms such as purulent discharge, pain, increased redness, swelling and tenderness in the surgical area within 30 days, they will be referred to a health institution for the detection of SSI	The infection will be evaluated in the hospital on the 7th day after surgery. An evaluation will be made by phone call on the 30th day after the operation.
Secondary	Perianesthesia Comfort Scale	Perianesthesia Comfort Scale, which consists of 24 items measuring the postoperative comfort level, will be applied.	Postoperative 0-1. day