Surgical Site InfectionNCT04187378
Effect of Active Warming on Surgical Site Infections
A study testing Surgical Underbody Blanket and Surgical access blanket in people with Surgical Site Infection and Ventral Hernia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of active warming by maintaining the normothermia during abdominal surgical procedures. The investigators hypothesize that there is no difference in terms of preventing surgical site infections between warm air blown surgical access blanket and underbody blanket. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgical Site Infection, Ventral Hernia
- What is being tested?
- Surgical Underbody Blanket and Surgical access blanket
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2020to 1 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists score I-II-III,
- 18-70 years old,
- Patients undergoing abdominal surgery (ventral hernia)
- Patients whose operation lasts longer than 30 minutes and less than 3 hours
Who cannot join
- Patients with American Society of Anesthesiologists score IV-V
- Patients with morbid obese (BMI> 40kg / m^2)
- Patients with neurological, psychiatric, neuromuscular disease
- Alcohol and drug addict patients
- Mental retarded patients
- Patients taking medications that affect thermoregulation, such as vasodilators
Show all 10Show fewer
- Patients with a history of thyroid disease
- Pregnant women
- Patients undergoing pre-intra-post-blood transfusion
- Patients with blood glucose levels above 200 mg / dl
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Muğla Sıtkı Koçman University Training and Research Hospital
Muğla
Cemile Çelebi, M.Sc., 905547276385, ccelebi48@gmail.com
About this study
Official title: The Effect of Maintenance of Normothermia With Active Warming on Surgical Site Infections in Patients Undergoing Abdominal Surgery
This study evaluates the effect of active warming by maintaining the normothermia during abdominal surgical procedures. The investigators hypothesize that there is no difference in terms of preventing surgical site infections between warm air blown surgical access blanket and underbody blanket.
Read the detailed description
Hypothermia is defined as a body temperature below 36°C and classified as mild (34°C-36°C), moderate (32°C-33.9°C), severe (<32°C) hypothermia. Hypothermia can be caused by reduced heat production, increased heat loss and / or deterioration of thermoregulation (anesthesia and premedication drugs, antiseptic solutions, low ambient temperature, wet surgical sterile drapes on the patient, use of cold intravenous fluids).
Preoperative, intraoperative and postoperative hypothermia is the drop of body temperature below 36 ° C within one hour before surgery and within 24 hours postoperatively. It is the most common but preventable thermal disorder during anesthesia. It occurs as a result of anesthesia on thermoregulation during surgery and exposure to cold operating room. Although it can be seen in all anesthetized individuals before, during and after surgery due to age, sex, body surface area and body shape; duration, depth, signs and symptoms may vary.
The American Society of Operating Room Nurses (AORN) emphasized the importance of the use of appropriate heating devices in the prevention of hypothermia in surgical patients. Experimental studies and meta-analyzes indicate that active methods of preventing hypothermia (hot air blown systems, hot water circulating blankets and garments, liquid heaters, blood and blood product heaters, etc.), passive methods (wool and synthetic woolen materials, garments and blankets, insulation) materials, etc.) are more effective. It is recommended to use more than one method together to maintain normothermia before, during and after surgery.
Hypothermia is an important problem that should be prevented in surgical patient because it causes serious problems such as delayed wound healing, bleeding, cardiac problems, deterioration of patient comfort, prolonged hospital stay, surgical site infection (SSI) and deaths.
Many guidelines state that the risk of surgical site infection increases three fold due to a decrease in central temperature of 1.9 C. According to the Guidelines for Safe Surgery published by the World Health Organization in 2009; maintaining normothermia during surgery is one of the ten steps intended to reduce the incidence of postoperative surgical site infection. The National Institute for Health and Care Excellence and the Association for Enhanced Recovery After Surgery (ERAS) recommend the maintenance of intraoperative normothermia to prevent surgical site infection.
Surgical nurse; should be aware of the causes of hypothermia and the complications that may occur during the planning, implementation and evaluation of a patient-specific, multi-faceted care; should check the body temperature before, during and after surgery and take precautions to prevent body temperature. Therefore, the body temperature of the patient should be monitored at regular intervals, the body temperature of the preventive interventions must be timely and effective implementation. The maintenance of normothermia in patients with perioperative procedures may reduce the incidence of complications due to hypothermia and may have a positive effect on the success and recovery of surgery.
- Conditions
- Surgical Site Infection, Ventral Hernia
- Being tested
- Surgical Underbody Blanket, Surgical access blanket
- Keywords
- Hypothermia, Surgical Wound Infection, Herniorrhaphy, Nursing care
- Medical subject headings
- Surgical Wound Infection, Hernia, Ventral, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Underbody BlanketDevice
Surgical blanket is used to maintain normothermia during abdominal surgery
Surgical access blanketDevice
Surgical blanket is used to maintain normothermia during abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Body temperature of the patients will be measured in the pre-operative service and in the waiting room. Sociodemographic characteristics form, preoperative, intra and postoperative evaluation forms will be completed. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form. |
| Underbody Blanket Group | Experimental | Patients with hypothermia (<36C) will be warmed by air blown underbody blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form. Receives: Device: Surgical Underbody Blanket |
| Surgical Access Blanket Group | Experimental | Patients with hypothermia (<36C) will be warmed by air blown surgical access blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form. Receives: Device: Surgical access blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Rate
The rate of surgical site infection will be monitored for each group by the case doctor and principle investigator. The patients will be diagnosed as Surgical Site Infection (SSI) according to CDC Guidelines if there is purulent wound drainage or serous but wound culture is positive within the postoperative 30 days.
Measured: Within the postoperative 30 days
Secondary outcomes (2)
Body Temperature
Before surgery, surgical access blanket or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an tympanic thermometer every 15 minutes during surgery and 2 hours after surgery. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm.
Measured: During the surgery and 2 hours after surgery (up to 300 minutes)
Duration of surgery
Minutes from skin incision until skin closure
Measured: Day 0 (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start10 Feb 2020
- Primary completion11 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile Celebi, M.Sc., Istanbul University - Cerrahpasa
- Investigators
- İkbal Çavdar, Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187378
- Sponsor's protocol ID
- 31102019-15/III
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Batsis JA, Naessens JM, Keegan MT, Huddleston PM, Wagie AE, Huddleston JM. Body mass index and the impact on hospital resource use in patients undergoing total knee arthroplasty. J Arthroplasty. 2010 Dec;25(8):1250-7.e1. doi: 10.1016/j.arth.2009.09.009. Epub 2010 Feb 19.
PubMed 20171045Bender M, Self B, Schroeder E, Giap B. Comparing new-technology passive warming versus traditional passive warming methods for optimizing perioperative body core temperature. AORN J. 2015 Aug;102(2):183.e1-8. doi: 10.1016/j.aorn.2015.06.005.
PubMed 26227528Cooper S. The effect of preoperative warming on patients' postoperative temperatures. AORN J. 2006 May;83(5):1073-6, 1079-84; quiz 1085-8. doi: 10.1016/s0001-2092(06)60118-x.
PubMed 16722285Deren ME, Machan JT, DiGiovanni CW, Ehrlich MG, Gillerman RG. Prewarming operating rooms for prevention of intraoperative hypothermia during total knee and hip arthroplasties. J Arthroplasty. 2011 Dec;26(8):1380-6. doi: 10.1016/j.arth.2010.12.019. Epub 2011 Feb 12.
PubMed 21316914Hart SR, Bordes B, Hart J, Corsino D, Harmon D. Unintended perioperative hypothermia. Ochsner J. 2011 Fall;11(3):259-70.
PubMed 21960760Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8.
PubMed 1610573Marino M, Masella R, Bulzomi P, Campesi I, Malorni W, Franconi F. Nutrition and human health from a sex-gender perspective. Mol Aspects Med. 2011 Feb;32(1):1-70. doi: 10.1016/j.mam.2011.02.001. Epub 2011 Feb 26.
PubMed 21356234Savage JW, Anderson PA. An update on modifiable factors to reduce the risk of surgical site infections. Spine J. 2013 Sep;13(9):1017-29. doi: 10.1016/j.spinee.2013.03.051. Epub 2013 May 24.
PubMed 23711958Sessler DI. Mild perioperative hypothermia. N Engl J Med. 1997 Jun 12;336(24):1730-7. doi: 10.1056/NEJM199706123362407. No abstract available.
PubMed 9180091Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
PubMed 30426190
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maintenance of Normothermia With Active Warming on Surgical Site Infections in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04187378
- Acronym / sponsor ID
- 31102019-15/III
- Conditions
- Surgical Site Infection, Ventral Hernia
- Keywords
- Hypothermia, Surgical Wound Infection, Herniorrhaphy, Nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 11 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 Dec 2019 (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.
This study evaluates the effect of active warming by maintaining the normothermia during abdominal surgical procedures. The investigators hypothesize that there is no difference in terms of preventing surgical site infections between warm air blown surgical access blanket and underbody blanket.
Detailed description
Hypothermia is defined as a body temperature below 36°C and classified as mild (34°C-36°C), moderate (32°C-33.9°C), severe (<32°C) hypothermia. Hypothermia can be caused by reduced heat production, increased heat loss and / or deterioration of thermoregulation (anesthesia and premedication drugs, antiseptic solutions, low ambient temperature, wet surgical sterile drapes on the patient, use of cold intravenous fluids).
Preoperative, intraoperative and postoperative hypothermia is the drop of body temperature below 36 ° C within one hour before surgery and within 24 hours postoperatively. It is the most common but preventable thermal disorder during anesthesia. It occurs as a result of anesthesia on thermoregulation during surgery and exposure to cold operating room. Although it can be seen in all anesthetized individuals before, during and after surgery due to age, sex, body surface area and body shape; duration, depth, signs and symptoms may vary.
The American Society of Operating Room Nurses (AORN) emphasized the importance of the use of appropriate heating devices in the prevention of hypothermia in surgical patients. Experimental studies and meta-analyzes indicate that active methods of preventing hypothermia (hot air blown systems, hot water circulating blankets and garments, liquid heaters, blood and blood product heaters, etc.), passive methods (wool and synthetic woolen materials, garments and blankets, insulation) materials, etc.) are more effective. It is recommended to use more than one method together to maintain normothermia before, during and after surgery.
Hypothermia is an important problem that should be prevented in surgical patient because it causes serious problems such as delayed wound healing, bleeding, cardiac problems, deterioration of patient comfort, prolonged hospital stay, surgical site infection (SSI) and deaths.
Many guidelines state that the risk of surgical site infection increases three fold due to a decrease in central temperature of 1.9 C. According to the Guidelines for Safe Surgery published by the World Health Organization in 2009; maintaining normothermia during surgery is one of the ten steps intended to reduce the incidence of postoperative surgical site infection. The National Institute for Health and Care Excellence and the Association for Enhanced Recovery After Surgery (ERAS) recommend the maintenance of intraoperative normothermia to prevent surgical site infection.
Surgical nurse; should be aware of the causes of hypothermia and the complications that may occur during the planning, implementation and evaluation of a patient-specific, multi-faceted care; should check the body temperature before, during and after surgery and take precautions to prevent body temperature. Therefore, the body temperature of the patient should be monitored at regular intervals, the body temperature of the preventive interventions must be timely and effective implementation. The maintenance of normothermia in patients with perioperative procedures may reduce the incidence of complications due to hypothermia and may have a positive effect on the success and recovery of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Body temperature of the patients will be measured in the pre-operative service and in the waiting room. Sociodemographic characteristics form, preoperative, intra and postoperative evaluation forms will be completed. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form. |
| Underbody Blanket Group | Experimental | Device: Surgical Underbody BlanketPatients with hypothermia (<36C) will be warmed by air blown underbody blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form. |
| Surgical Access Blanket Group | Experimental | Device: Surgical access blanketPatients with hypothermia (<36C) will be warmed by air blown surgical access blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with American Society of Anesthesiologists score I-II-III,
- 18-70 years old,
- Patients undergoing abdominal surgery (ventral hernia)
- Patients whose operation lasts longer than 30 minutes and less than 3 hours
Key exclusion criteria (10 listed)
- Patients with American Society of Anesthesiologists score IV-V
- Patients with morbid obese (BMI> 40kg / m^2)
- Patients with neurological, psychiatric, neuromuscular disease
- Alcohol and drug addict patients
- Mental retarded patients
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 Underbody BlanketSurgical blanket is used to maintain normothermia during abdominal surgery | Device | Underbody Blanket Group |
| Surgical access blanketSurgical blanket is used to maintain normothermia during abdominal surgery | Device | Surgical Access Blanket Group |
Primary outcome
Surgical Site Infection Rate
Time frame: Within the postoperative 30 days
The rate of surgical site infection will be monitored for each group by the case doctor and principle investigator. The patients will be diagnosed as Surgical Site Infection (SSI) according to CDC Guidelines if there is purulent wound drainage or serous but wound culture is positive within the postoperative 30 days.
2 secondary outcomes
Body Temperature
Time frame: During the surgery and 2 hours after surgery (up to 300 minutes)
Duration of surgery
Time frame: Day 0 (day of surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 20171045Batsis JA, Naessens JM, Keegan MT, Huddleston PM, Wagie AE, Huddleston JM. Body mass index and the impact on hospital resource use in patients undergoing total knee arthroplasty. J Arthroplasty. 2010 Dec;25(8):1250-7.e1. doi: 10.1016/j.arth.2009.09.009. Epub 2010 Feb 19.
- Background: PubMed 26227528Bender M, Self B, Schroeder E, Giap B. Comparing new-technology passive warming versus traditional passive warming methods for optimizing perioperative body core temperature. AORN J. 2015 Aug;102(2):183.e1-8. doi: 10.1016/j.aorn.2015.06.005.
- Background: PubMed 16722285Cooper S. The effect of preoperative warming on patients' postoperative temperatures. AORN J. 2006 May;83(5):1073-6, 1079-84; quiz 1085-8. doi: 10.1016/s0001-2092(06)60118-x.
- Background: PubMed 21316914Deren ME, Machan JT, DiGiovanni CW, Ehrlich MG, Gillerman RG. Prewarming operating rooms for prevention of intraoperative hypothermia during total knee and hip arthroplasties. J Arthroplasty. 2011 Dec;26(8):1380-6. doi: 10.1016/j.arth.2010.12.019. Epub 2011 Feb 12.
- Background: PubMed 21960760Hart SR, Bordes B, Hart J, Corsino D, Harmon D. Unintended perioperative hypothermia. Ochsner J. 2011 Fall;11(3):259-70.
- Background: PubMed 1610573Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8.
- Background: PubMed 21356234Marino M, Masella R, Bulzomi P, Campesi I, Malorni W, Franconi F. Nutrition and human health from a sex-gender perspective. Mol Aspects Med. 2011 Feb;32(1):1-70. doi: 10.1016/j.mam.2011.02.001. Epub 2011 Feb 26.
- Background: PubMed 23711958Savage JW, Anderson PA. An update on modifiable factors to reduce the risk of surgical site infections. Spine J. 2013 Sep;13(9):1017-29. doi: 10.1016/j.spinee.2013.03.051. Epub 2013 May 24.
- Background: PubMed 9180091Sessler DI. Mild perioperative hypothermia. N Engl J Med. 1997 Jun 12;336(24):1730-7. doi: 10.1056/NEJM199706123362407. No abstract available.
- Background: PubMed 30426190Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- The Essentials of Maintaining Patient NormothermiaLink provided by the sponsor.
- Surgical site infections: prevention and treatmentLink provided by the sponsor.
- 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.
İkbal Çavdar, Professor study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Underbody Blanket and Surgical access blanket in people with Surgical Site Infection and Ventral Hernia, run by Istanbul University - Cerrahpasa at 1 site 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 4 inclusion and 10 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Cemile Çelebi, M.Sc. (+905547276385, ccelebi48@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection Rate (time frame: Within the postoperative 30 days). 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 NCT04187378, which also lists 10 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 1 Apr 2022.