Antibiotic ReactionNCT06510452
Antibiotic Prophylaxis in Metabolic Bariatric Surgery
A study testing 2000 mg of Cefazolin, 500 mg of Metronidazole IV and NACL 0.9% 100 ml in people with Antibiotic Reaction and Wound Infection Superficial, run by General Committee of Teaching Hospitals and Institutes, Egypt at 2 sites in 2 countries.
Trial summary
SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Reaction, Wound Infection Superficial, Wound Infection Deep
- What is being tested?
- 2000 mg of Cefazolin, 500 mg of Metronidazole IV and NACL 0.9% 100 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,352 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2024to 1 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ° Patients must be older than 18 and meet the eligibility criteria for MBS as outlined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the Dutch Federation of Medical Specialists for the surgical treatment of obesity.
Who cannot join
- Patients undergoing immunotherapy or corticosteroid treatment for Crohn's disease or rheumatoid arthritis.
- Patients with a history of endocarditis require prophylactic antibiotics.
- Patients with known severe allergies to antibiotics.
- Patients with active infections or recently treated with antibiotics (within the last 30 days).
- Patients with compromised immune systems, including those with HIV/AIDS or undergoing chemotherapy.
- Patients with chronic liver or kidney disease.
Show all 10Show fewer
- Patients with uncontrolled diabetes (HbA1c > 9%).
- Patients with a history of previous metabolic bariatric surgery.
- Pregnant or breastfeeding women.
- Patients with any other medical condition that, in the opinion of the investigator, would compromise the patient's safety or the study's integrity.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
WeightWorks clinics
Amersfoort, Utrecht
Bart Torensma, MSc PhD, +31641389070, bart@torensmaresearch.nl
Frits Berends, MD, PhD, +31655100534, berends@weightworks.nl
About this study
Official title: Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery: A Randomized Controlled Trial
SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. However, since incisional wound infections in laparoscopic MBS are rare and morbidity is very low, the benefit of antibiotic prophylaxis is questionable.
Objective: Evaluate the non-inferiority of omitting antibiotic prophylaxis in MBS. Compare postoperative outcomes between Group A (no antibiotics) and Group B (standard antibiotic care) to determine if omission increases complications, particularly wound infections.
Read more
Study Design: Randomized controlled trial (RCT), double-blind.
Study Population: Patients with obesity eligible for MBS.
Intervention:
- Group A (No Antibiotic Prophylaxis): Undergo MBS without antibiotics to test safety regarding postoperative complications, focusing on surgical site infections (SSIs).
- Group B (Standard Antibiotic Prophylaxis): Receive standard one-time antibiotics before incision.
Main Study Parameters/Endpoints: Compare the incidence of incisional and organ/space SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates.
Read the detailed description
Nature and Extent of the Burden and Risks:
Rationale:
- Cost-Effectiveness: Reducing antibiotic use could lower surgical costs.
- Resource Utilization: Simplifying protocols save hospital resources.
- Antibiotic Resistance: Reducing use helps combat resistant bacteria.
- Adverse Reactions: Fewer antibiotics may reduce side effects.
Risk Assessment:
- Increased Infection Rates: Monitor SSI and organ/space SSI rates closely.
- Anastomotic Leaks and Reoperations: Assess the impact on leaks and operations.
- Readmissions and Postoperative Interventions: Evaluate the effect on readmission and intervention rates.
Group Relatedness:
Comparing groups with and without antibiotics provides evi-dence-based insights into the safety of modifying standard practices to optimize health outcomes and resource use.
- Conditions
- Antibiotic Reaction, Wound Infection Superficial, Wound Infection Deep, Bariatric Surgery Candidate, Complication,Postoperative
- Being tested
- 2000 mg of Cefazolin, 500 mg of Metronidazole IV, NACL 0.9% 100 ml
- Keywords
- anti-biotics, non-inferiority, surgical side infection
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2000 mg of CefazolinDrug
Also called Kefzol
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
500 mg of Metronidazole IVDrug
Also called Flagyl
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
NACL 0.9% 100 mlDrug
Also called Saline
receive 100 ml NACL0.9% without any antibiotics in it.
| Study group | Role | What they receive |
|---|---|---|
| NACL0.9% | Experimental | Group A will receive 100 ml NACL0.9% without any antibiotics in it. Receives: Drug: NACL 0.9% 100 ml |
| Cefazolin +Metronidazole | Active comparator | Group B will receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%. Both antibiotics will be administered at least 30 minutes before surgery to ensure adequate tissue concentrations at the time of incision. Receives: Drug: 2000 mg of Cefazolin; Drug: 500 mg of Metronidazole IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of incidence of postoperative wound infections in both treatment arms
Aims to evaluate the non-inferiority of foregoing antibiotic prophylaxis in MBS. The study will compare postoperative outcomes between two groups: Group A, which will not receive antibiotic prophylaxis, and Group B, which will receive standard care including a one-time administration of antibiotics, to test the hypothesis that omitting antibiotic prophylaxis does not significantly increase the incidence of postoperative complications, in particular wound infections.
Measured: until 6 weeks post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Antibiotic ReactionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510452
- Sponsor's protocol ID
- AB-BAR-2024
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analysis will be performed on a blinded dataset after the completion of the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com) and handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers, where all the research data were stored, are certified according to ISO27001, ISO9001, and Dutch NEN7510.
Publications
CDC antimicrobial resistance. Available from: https://www.cdc.gov/drugresistance/about.html
Aktas A, Kayaalp C, Gunes O, Kirkil C, Tardu A, Aydin MC, Bag YM, Cayci HM, Arslan U, Sumer F, Aygen E. Surgical Site Infections after Laparoscopic Bariatric Surgery: Is Routine Antibiotic Prophylaxis Required? Surg Infect (Larchmt). 2021 Sep;22(7):705-712. doi: 10.1089/sur.2020.426. Epub 2021 Jan 8.
PubMed 33416442Dang JT, Tran C, Switzer N, Delisle M, Laffin M, Madsen K, Birch DW, Karmali S. Predicting surgical site infections following laparoscopic bariatric surgery: development of the BariWound tool using the MBSAQIP database. Surg Endosc. 2020 Apr;34(4):1802-1811. doi: 10.1007/s00464-019-06932-6. Epub 2019 Jun 24.
PubMed 31236724Shope TR, Cooney RN, McLeod J, Miller CA, Haluck RS. Early results after laparoscopic gastric bypass: EEA vs GIA stapled gastrojejunal anastomosis. Obes Surg. 2003 Jun;13(3):355-9. doi: 10.1381/096089203765887651.
PubMed 12841893Alasfar F, Sabnis A, Liu R, Chand B. Reduction of circular stapler-related wound infection in patients undergoing laparoscopic Roux-en-Y gastric bypass, Cleveland clinic technique. Obes Surg. 2010 Feb;20(2):168-72. doi: 10.1007/s11695-008-9708-3. Epub 2008 Oct 7.
PubMed 18839083Schauer PR, Ikramuddin S, Gourash W, Ramanathan R, Luketich J. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000 Oct;232(4):515-29. doi: 10.1097/00000658-200010000-00007.
PubMed 10998650Finks JF, Carlin A, Share D, O'Reilly A, Fan Z, Birkmeyer J, Birkmeyer N; Michigan Bariatric Surgery Collaborative from the Michigan Surgical Collaborative for Outcomes Research Evaluation. Effect of surgical techniques on clinical outcomes after laparoscopic gastric bypass--results from the Michigan Bariatric Surgery Collaborative. Surg Obes Relat Dis. 2011 May-Jun;7(3):284-9. doi: 10.1016/j.soard.2010.10.004. Epub 2010 Oct 16.
PubMed 21126927Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
PubMed 10219875Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.
PubMed 23461695Anderson DJ, Podgorny K, Berrios-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S66-88. doi: 10.1017/s0899823x00193869. No abstract available.
PubMed 25376070De Luca M, Angrisani L, Himpens J, Busetto L, Scopinaro N, Weiner R, Sartori A, Stier C, Lakdawala M, Bhasker AG, Buchwald H, Dixon J, Chiappetta S, Kolberg HC, Fruhbeck G, Sarwer DB, Suter M, Soricelli E, Bluher M, Vilallonga R, Sharma A, Shikora S. Indications for Surgery for Obesity and Weight-Related Diseases: Position Statements from the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Obes Surg. 2016 Aug;26(8):1659-96. doi: 10.1007/s11695-016-2271-4. No abstract available.
PubMed 27412673Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery. Obes Surg. 2023 Jan;33(1):3-14. doi: 10.1007/s11695-022-06332-1.
PubMed 36336720Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.
PubMed 20934625Jourdan A, Sangha B, Kim E, Nawaz S, Malik V, Vij R, Sekhsaria S. Antibiotic hypersensitivity and adverse reactions: management and implications in clinical practice. Allergy Asthma Clin Immunol. 2020 Jan 21;16:6. doi: 10.1186/s13223-020-0402-x. eCollection 2020.
PubMed 31993070WHO antimicrobial resistance. Available from: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06510452
- Acronym / sponsor ID
- AB-BAR-2024
- Conditions
- Antibiotic Reaction, Wound Infection Superficial, Wound Infection Deep, Bariatric Surgery Candidate, Complication,Postoperative
- Keywords
- anti-biotics, non-inferiority, surgical side infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,352 participants (estimated)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Jul 2024 (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.
SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. However, since incisional wound infections in laparoscopic MBS are rare and morbidity is very low, the benefit of antibiotic prophylaxis is questionable.
Objective: Evaluate the non-inferiority of omitting antibiotic prophylaxis in MBS. Compare postoperative outcomes between Group A (no antibiotics) and Group B (standard antibiotic care) to determine if omission increases complications, particularly wound infections.
Study Design: Randomized controlled trial (RCT), double-blind.
Study Population: Patients with obesity eligible for MBS.
Intervention:
- Group A (No Antibiotic Prophylaxis): Undergo MBS without antibiotics to test safety regarding postoperative complications, focusing on surgical site infections (SSIs).
- Group B (Standard Antibiotic Prophylaxis): Receive standard one-time antibiotics before incision.
Main Study Parameters/Endpoints: Compare the incidence of incisional and organ/space SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates.
Detailed description
Nature and Extent of the Burden and Risks:
Rationale:
- Cost-Effectiveness: Reducing antibiotic use could lower surgical costs.
- Resource Utilization: Simplifying protocols save hospital resources.
- Antibiotic Resistance: Reducing use helps combat resistant bacteria.
- Adverse Reactions: Fewer antibiotics may reduce side effects.
Risk Assessment:
- Increased Infection Rates: Monitor SSI and organ/space SSI rates closely.
- Anastomotic Leaks and Reoperations: Assess the impact on leaks and operations.
- Readmissions and Postoperative Interventions: Evaluate the effect on readmission and intervention rates.
Group Relatedness:
Comparing groups with and without antibiotics provides evi-dence-based insights into the safety of modifying standard practices to optimize health outcomes and resource use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NACL0.9% | Experimental | Drug: NACL 0.9% 100 mlGroup A will receive 100 ml NACL0.9% without any antibiotics in it. |
| Cefazolin +Metronidazole | Active comparator | Drug: 2000 mg of Cefazolin, Drug: 500 mg of Metronidazole IVGroup B will receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%. Both antibiotics will be administered at least 30 minutes before surgery to ensure adequate tissue concentrations at the time of incision. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ° Patients must be older than 18 and meet the eligibility criteria for MBS as outlined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the Dutch Federation of Medical Specialists for the surgical treatment of obesity.
Key exclusion criteria (10 listed)
- Patients undergoing immunotherapy or corticosteroid treatment for Crohn's disease or rheumatoid arthritis.
- Patients with a history of endocarditis require prophylactic antibiotics.
- Patients with known severe allergies to antibiotics.
- Patients with active infections or recently treated with antibiotics (within the last 30 days).
- Patients with compromised immune systems, including those with HIV/AIDS or undergoing chemotherapy.
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 |
|---|---|---|
| 2000 mg of CefazolinAlso: Kefzolreceive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%. | Drug | Cefazolin +Metronidazole |
| 500 mg of Metronidazole IVAlso: Flagylreceive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%. | Drug | Cefazolin +Metronidazole |
| NACL 0.9% 100 mlAlso: Salinereceive 100 ml NACL0.9% without any antibiotics in it. | Drug | NACL0.9% |
Primary outcome
Comparison of incidence of postoperative wound infections in both treatment arms
Time frame: until 6 weeks post operative
Aims to evaluate the non-inferiority of foregoing antibiotic prophylaxis in MBS. The study will compare postoperative outcomes between two groups: Group A, which will not receive antibiotic prophylaxis, and Group B, which will receive standard care including a one-time administration of antibiotics, to test the hypothesis that omitting antibiotic prophylaxis does not significantly increase the incidence of postoperative complications, in particular wound infections.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- BackgroundCDC antimicrobial resistance. Available from: https://www.cdc.gov/drugresistance/about.html
- Results publication: PubMed 33416442Aktas A, Kayaalp C, Gunes O, Kirkil C, Tardu A, Aydin MC, Bag YM, Cayci HM, Arslan U, Sumer F, Aygen E. Surgical Site Infections after Laparoscopic Bariatric Surgery: Is Routine Antibiotic Prophylaxis Required? Surg Infect (Larchmt). 2021 Sep;22(7):705-712. doi: 10.1089/sur.2020.426. Epub 2021 Jan 8.
- Results publication: PubMed 31236724Dang JT, Tran C, Switzer N, Delisle M, Laffin M, Madsen K, Birch DW, Karmali S. Predicting surgical site infections following laparoscopic bariatric surgery: development of the BariWound tool using the MBSAQIP database. Surg Endosc. 2020 Apr;34(4):1802-1811. doi: 10.1007/s00464-019-06932-6. Epub 2019 Jun 24.
- Results publication: PubMed 12841893Shope TR, Cooney RN, McLeod J, Miller CA, Haluck RS. Early results after laparoscopic gastric bypass: EEA vs GIA stapled gastrojejunal anastomosis. Obes Surg. 2003 Jun;13(3):355-9. doi: 10.1381/096089203765887651.
- Results publication: PubMed 18839083Alasfar F, Sabnis A, Liu R, Chand B. Reduction of circular stapler-related wound infection in patients undergoing laparoscopic Roux-en-Y gastric bypass, Cleveland clinic technique. Obes Surg. 2010 Feb;20(2):168-72. doi: 10.1007/s11695-008-9708-3. Epub 2008 Oct 7.
- Results publication: PubMed 10998650Schauer PR, Ikramuddin S, Gourash W, Ramanathan R, Luketich J. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000 Oct;232(4):515-29. doi: 10.1097/00000658-200010000-00007.
- Results publication: PubMed 21126927Finks JF, Carlin A, Share D, O'Reilly A, Fan Z, Birkmeyer J, Birkmeyer N; Michigan Bariatric Surgery Collaborative from the Michigan Surgical Collaborative for Outcomes Research Evaluation. Effect of surgical techniques on clinical outcomes after laparoscopic gastric bypass--results from the Michigan Bariatric Surgery Collaborative. Surg Obes Relat Dis. 2011 May-Jun;7(3):284-9. doi: 10.1016/j.soard.2010.10.004. Epub 2010 Oct 16.
- Results publication: PubMed 10219875Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
- Results publication: PubMed 23461695Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.
- Results publication: PubMed 25376070Anderson DJ, Podgorny K, Berrios-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S66-88. doi: 10.1017/s0899823x00193869. No abstract available.
- Results publication: PubMed 27412673De Luca M, Angrisani L, Himpens J, Busetto L, Scopinaro N, Weiner R, Sartori A, Stier C, Lakdawala M, Bhasker AG, Buchwald H, Dixon J, Chiappetta S, Kolberg HC, Fruhbeck G, Sarwer DB, Suter M, Soricelli E, Bluher M, Vilallonga R, Sharma A, Shikora S. Indications for Surgery for Obesity and Weight-Related Diseases: Position Statements from the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Obes Surg. 2016 Aug;26(8):1659-96. doi: 10.1007/s11695-016-2271-4. No abstract available.
- Results publication: PubMed 36336720Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery. Obes Surg. 2023 Jan;33(1):3-14. doi: 10.1007/s11695-022-06332-1.
- Individual participant dataSharing planned: Yes. The analysis will be performed on a blinded dataset after the completion of the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com) and handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers, where all the research data were stored, are certified according to ISO27001, ISO9001, and Dutch NEN7510.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2000 mg of Cefazolin, 500 mg of Metronidazole IV and NACL 0.9% 100 ml in people with Antibiotic Reaction and Wound Infection Superficial, run by General Committee of Teaching Hospitals and Institutes, Egypt at 2 sites in 2 countries.
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 1 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 31 Jul 2024. 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 Egypt, Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of incidence of postoperative wound infections in both treatment arms (time frame: until 6 weeks post operative). 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 NCT06510452, which also lists 16 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 31 Jul 2024.