Bariatric Surgery CandidateNCT05930639
The Effect of the Care Bundle to be Applied to Obesity Surgery Patients on Surgical Site Infection and Patient Comfort
A study testing Surgical Site Infection (SSI) prevention package in people with Bariatric Surgery Candidate, run by Malatya Turgut Ozal University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Surgical Site Infection (SSI) prevention package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Jun 2023to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and over
- undergoing sleeve gastrectomy surgery
- who volunteered to participate in the study
Who cannot join
- under 18 years old
- Surgeries other than sleeve gastrectomy
- not willing to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Hatice ÇAKIR
Malatya
Hatice ÇAKIR (RESEARCH ASSISTANT), +90 05534491539, hatice.cakir@ozal.edu.tr
Meryem YILMAZ
- Recruiting
Meryem Yilmaz
Sivas
MERYEM YILMAZ (PROFESSOR), +90 0531 010 2028, yilmazmm01@hotmail.com
About this study
Official title: The Effect of Care Bundle Applied to Patients Undergoing Bariatric Surgery on Surgical Site ınfection and Comfort
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.
Read more
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.
Read the detailed 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Surgical Site Infection (SSI) prevention package
- Keywords
- Surgical Site Infection, Bariatric Surgery, Care bundle, prevention package
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Site Infection (SSI) prevention packageOther
Also called care bundle, care 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Site Infection (SSI) prevention package; Identification of risk factors | Experimental | Risk factors of the individual created in line with the literature; Advanced age, history of skin or soft tissue infection, DM, alcohol addiction, smoking, preoperative albumin <3.5 mg/dl, total bilirubin>1.0 mg/dl, immunosuppression, long postoperative stay, long preoperative stay, high BMI,ASA score > II,preoperative low Hgb level.
Risk factors associated with the surgical procedure; Presence of drain, prolongation of surgery time, preoperative skin preparation, blood transfusion, non-sterile equipment, insufficient ventilation, heavy operating room traffic, insufficient hemostasis.
Participants will be evaluated in terms of these risks. Receives: Other: Surgical Site Infection (SSI) prevention package |
| Surgical Site Infection (SSI) prevention package; Antibiotic prophylaxis | Experimental | determined antibiotic (active ingredient: imipenem cilastatin sodium) Receives: Other: Surgical Site Infection (SSI) prevention package |
| Surgical Site Infection (SSI) prevention package;achieving and maintaining normothermia | Experimental | Body temperature will be recorded with an infrared thermometer. The patient will be warmed with various passive heating techniques before and after the operation. To prevent hypothermia, the operating room ambient temperature will be kept in the range of 23-26°C. Receives: Other: Surgical Site Infection (SSI) prevention package |
| Surgical Site Infection (SSI) prevention package; maintenance of normoglycemia | Experimental | In the 2017 guidelines, perioperative glycemic control with a blood glucose level of <200 mg/dL is recommended for patients with and without DM. Ideal blood glucose control should provide good glycemic control with a minimal incidence of hypoglycemia. Receives: Other: Surgical Site Infection (SSI) prevention package |
| Surgical Site Infection (SSI) prevention package;patient education | Experimental | SSI definition, SSI signs and symptoms, Hand hygiene, smoking, hair removal in the operation area, shower and bath before surgery. Conditions that require hospitalization, factors affecting wound healing, wound care, control time and who should be contacted will be discussed. Receives: Other: Surgical Site Infection (SSI) prevention package |
| control group | No intervention | Antibiotic prophylaxis is applied to both groups. In the clinic where the study will be conducted, the blood glucose level of patients with a diagnosis of DM is controlled (5 measurements per day). All patients are fasted after 21.00 in the evening. The blood glucose levels of patients without a diagnosis of DM are not routinely checked. The body temperature of the patients is not monitored intraoperatively. No extra intervention is applied to maintain normothermia in the clinic and operating room. There is no training on prevention of infection. There is no intervention in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
Perianesthesia Comfort Scale
Perianesthesia Comfort Scale, which consists of 24 items measuring the postoperative comfort level, will be applied.
Measured: Postoperative 0-1. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start12 Jun 2023
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malatya Turgut Ozal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice ÇAKIR, Malatya Turgut Ozal University
- Investigators
- Meryem YILMAZ, Study director, SİVAS CUMHURİYET UNIVERSITYHatice ÇAKIR, Principal investigator, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930639
- Sponsor's protocol ID
- 2022-07-22/30
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26114986Horan 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.
PubMed 18538699Isik 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.
PubMed 26531790Haridas 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.
PubMed 18847631Alkaaki 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.
PubMed 30907567Carvalho 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.
PubMed 29211190Wang 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.
PubMed 30986636Chopra 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.
PubMed 20545596Berrios-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.
PubMed 28467526Tsuchida 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.
PubMed 27027205Zellmer 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.
PubMed 25541334Ban 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.
PubMed 27915053Weiser 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.
PubMed 29974946Cakir H, Yilmaz M. Impact of a Care Bundle on Surgical Site Infections and Patient Comfort in Bariatric Surgery: A Randomized Prospective Study. Obes Surg. 2025 Sep;35(9):3810-3821. doi: 10.1007/s11695-025-08116-9. Epub 2025 Aug 23.
PubMed 40848119
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Care Bundle Applied to Patients Undergoing Bariatric Surgery on Surgical Site ınfection and Comfort
- ClinicalTrials.gov ID
- NCT05930639
- Acronym / sponsor ID
- 2022-07-22/30
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Surgical Site Infection, Bariatric Surgery, Care bundle, prevention package
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Malatya Turgut Ozal UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Surgical Site Infection (SSI) prevention package; Identification of risk factors | Experimental | Other: Surgical Site Infection (SSI) prevention packageRisk factors of the individual created in line with the literature; Advanced age, history of skin or soft tissue infection, DM, alcohol addiction, smoking, preoperative albumin <3.5 mg/dl, total bilirubin>1.0 mg/dl, immunosuppression, long postoperative stay, long preoperative stay, high BMI,ASA score > II,preoperative low Hgb level. Risk factors associated with the surgical procedure; Presence of drain, prolongation of surgery time, preoperative skin preparation, blood transfusion, non-sterile equipment, insufficient ventilation, heavy operating room traffic, insufficient hemostasis. Participants will be evaluated in terms of these risks. |
| Surgical Site Infection (SSI) prevention package; Antibiotic prophylaxis | Experimental | Other: Surgical Site Infection (SSI) prevention packagedetermined antibiotic (active ingredient: imipenem cilastatin sodium) |
| Surgical Site Infection (SSI) prevention package;achieving and maintaining normothermia | Experimental | Other: Surgical Site Infection (SSI) prevention packageBody temperature will be recorded with an infrared thermometer. The patient will be warmed with various passive heating techniques before and after the operation. To prevent hypothermia, the operating room ambient temperature will be kept in the range of 23-26°C. |
| Surgical Site Infection (SSI) prevention package; maintenance of normoglycemia | Experimental | Other: Surgical Site Infection (SSI) prevention packageIn the 2017 guidelines, perioperative glycemic control with a blood glucose level of <200 mg/dL is recommended for patients with and without DM. Ideal blood glucose control should provide good glycemic control with a minimal incidence of hypoglycemia. |
| Surgical Site Infection (SSI) prevention package;patient education | Experimental | Other: Surgical Site Infection (SSI) prevention packageSSI definition, SSI signs and symptoms, Hand hygiene, smoking, hair removal in the operation area, shower and bath before surgery. Conditions that require hospitalization, factors affecting wound healing, wound care, control time and who should be contacted will be discussed. |
| control group | No intervention | –Antibiotic prophylaxis is applied to both groups. In the clinic where the study will be conducted, the blood glucose level of patients with a diagnosis of DM is controlled (5 measurements per day). All patients are fasted after 21.00 in the evening. The blood glucose levels of patients without a diagnosis of DM are not routinely checked. The body temperature of the patients is not monitored intraoperatively. No extra intervention is applied to maintain normothermia in the clinic and operating room. There is no training on prevention of infection. There is no intervention in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and over
- undergoing sleeve gastrectomy surgery
- who volunteered to participate in the study
Key exclusion criteria (3 listed)
- under 18 years old
- Surgeries other than sleeve gastrectomy
- not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Site Infection (SSI) prevention packageAlso: care bundle, care packageCare 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. | Other | Surgical Site Infection (SSI) prevention package; Antibiotic prophylaxis, Surgical Site Infection (SSI) prevention package; Identification of risk factors, Surgical Site Infection (SSI) prevention package; maintenance of normoglycemia, Surgical Site Infection (SSI) prevention package;achieving and maintaining normothermia, Surgical Site Infection (SSI) prevention package;patient education |
Primary outcome
Surgery Site Infection
Time frame: 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.
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
1 secondary outcome
Perianesthesia Comfort Scale
Time frame: Postoperative 0-1. day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background: PubMed 26114986Aga 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.
- Background: PubMed 18538699Horan 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.
- Background: PubMed 26531790Isik 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.
- Background: PubMed 18847631Haridas 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.
- Background: PubMed 30907567Alkaaki 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.
- Background: PubMed 29211190Carvalho 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem YILMAZ study director
SİVAS CUMHURİYET UNIVERSITY
Hatice ÇAKIR principal investigator
Malatya Turgut Ozal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Site Infection (SSI) prevention package in people with Bariatric Surgery Candidate, run by Malatya Turgut Ozal University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact research assistant (+90 05534491539, hatice.cakir@ozal.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery Site Infection (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930639, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.