Topical Antibiotics in Surgical Site
Primary Purpose
Surgical Site Infection, Complication of Surgical Procedure
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Vancomycin 1000 MG
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Antibiotic, Surgical site infection, Ankle fractures, Complication
Eligibility Criteria
Inclusion Criteria:
• Patients older than 18 years
- Patients with a closed fracture independently of mechanism and classification
- Patients who require an open reduction with internal fixation surgery
- Patients who decide to participate in the study
Exclusion Criteria:
- Patients with exposed fractures
- Presence of any form of immune deficiency
- Vancomycin hyper sensibility
- Surgery in the affected ankle within the last six months
- Steroid usage
- Antibiotic usage one week prior entry
Sites / Locations
- Hospital Universitario "Dr. José E. González"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ankle fracture surgical treated plus 1 g of topical vancomycin
Ankle fracture surgical treated
Arm Description
A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system. Plus application of 1 g of vancomycin in powder in the surgical site
A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system
Outcomes
Primary Outcome Measures
Rate of surgical infection site
Defined as the number of patients with surgical infection site from the total of evaluated patients included in each group.
Secondary Outcome Measures
Full Information
NCT ID
NCT05363462
First Posted
May 2, 2022
Last Updated
March 23, 2023
Sponsor
Universidad Autonoma de Nuevo Leon
1. Study Identification
Unique Protocol Identification Number
NCT05363462
Brief Title
Topical Antibiotics in Surgical Site
Official Title
Use of Topical Broad-spectrum Antibiotics as a Prophylaxis for Surgical Site Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
July 21, 2023 (Anticipated)
Study Completion Date
September 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Nuevo Leon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ankle fractures are one of the most common injuries in traumatology. It is the fourth most common fracture in general population after hip, wrist, and hand fractures. These injuries are the second cause of hospitalization due to fractures.
Surgical site infections can be divided according to the Center of Disease Control (CDC) in superficial surgical site infections whose are defined as any infection that happens within the next 30 days after the procedure, they involve only the skin and subcutaneous tissue of the incision, and the patient presents at least one of the following: purulent drainage of the superficial incision, microorganisms isolation from an aseptically obtained culture of body fluid or tissue or the pain existence, tenderness or local inflammation at the superficial incision site despite negative cultures. Also, a diagnosis made by the surgeon or attending medic.
Detailed Description
Ankle fractures are one of the most common injuries in traumatology. It is the fourth most common fracture in general population after hip, wrist, and hand fractures. These injuries are the second cause of hospitalization due to fractures. Despite the improvement in the ankle fracture management, it has been estimated that the ankle fracture incidence has been increasing and one of the motives is an increase of ageing population. It has been estimated that ankle fractures have an incidence between 71 to 187 cases per 100,000 inhabitants a year.
Most of the ankle fractures are due to fallings or traffic accidents, it has been reported that up to 71% from ankle fracture causes are due to mechanisms of low energy, especially among the elderly and those with comorbidities these injuries are commonly caused by the inversion of the ankle, where the force and weight of the body falls in the fibula, which in young individuals usually results in only an ankle sprain, being the conservative management the most effective treatment. Nevertheless, in aging patients, these same mechanisms can provoke a fracture.
Ankle fractures represent a challenge for the orthopedic surgeon because in this very joint, despite being relatively stable, rests the entire bodyweight and a correct approach is required for the functionality to not being affected.
Ankle fractures are classified according to AO/OTA and Danis-Weber classifications. Single malleolus fractures are the most frequent (43.7 - 10%) and inside the Orthopedic Trauma Association (OTA) classification, type B are more common with a 65.8%, which tend to be displaced fractures. In patients with unstable or displaced fractures, or where a severe dislocation exists, surgical intervention is advised.
These injuries require a surgical treatment, which brings another issue: surgical site infections.
Surgical site infections can be divided according to the CDC in superficial surgical site infections whose are defined as any infection that happens within the next 30 days after the procedure, they involve only the skin and subcutaneous tissue of the incision, and the patient presents at least one of the following: purulent drainage of the superficial incision, microorganisms isolation from an aseptically obtained culture of body fluid or tissue or the pain existence, tenderness or local inflammation at the superficial incision site despite negative cultures. Also, a diagnosis made by the surgeon or attending medic.
Deep incisional surgical site infections are defined as:
An infection that occurs within the next 30 days after the surgery if no implant is there or a year after the surgery if there is an implant and the infection seems to be related with the procedure, where involves the deep tissue as fascial and muscular layers and presents:
Purulent drainage from the deep incision
Surgical incision that opens spontaneously or deliberately opened by a surgeon, and a positive culture
If there is no positive culture, the presence of fever (> 38° Celsius degrees), pain or tenderness.
An abscess or a diagnosis made by a surgeon or the attending medic. There are established risk factors for the development of surgical site infections, some of them are patient age, nutritional state, diabetes, smoking, obesity, altered immune state (8) and bacteria colonization due to contamination. This is relevant because S. aureus, negative coagulase Staphylococcus or Enterococcus are the most common causal agents for surgical site infections, which tend to be multiresistant to the most used antibiotics.
There is controversy in the prophylactic usage of antibiotics in the management of surgical injuries. The available literature supports the usage of prophylactic IV antibiotics 1 hour prior procedure and until 48 hours after, as defined by lead surgeon. Other prophylactic management is the usage of topical broad-spectrum antibiotics.
The information about the usage of topical broad-spectrum antibiotics is equally controversial. Topical vancomycin is advised in patients with surgeries that involve a high risk of developing severe and resistant infections such as spine, thorax, or cranium surgery, where its application has shown a decrease of surgical site infection acquisition risk. In one study, topical antibiotic application was carried out by irrigating 2.5 g of Vancomycin dissolved in 2 mL of saline solution before sternum incision, and at the procedure ending after injury closure. In some other studies 1 g of Vancomycin powder was placed over the cranium, then irrigated with saline solution before injury closure.
Nevertheless, these prophylaxis therapy has not been evaluated in patients under open ankle surgery with intern fixation. The available literature about these patients' management doesn´t oppose to the general surgical site infection guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Complication of Surgical Procedure
Keywords
Antibiotic, Surgical site infection, Ankle fractures, Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of treatment with a surgical ankle fracture
Surgical treatment
Surgical treatment plus 1 g of topical vancomycin
Masking
Participant
Masking Description
The patients involved in the protocol will be blinded
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ankle fracture surgical treated plus 1 g of topical vancomycin
Arm Type
Experimental
Arm Description
A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system. Plus application of 1 g of vancomycin in powder in the surgical site
Arm Title
Ankle fracture surgical treated
Arm Type
Active Comparator
Arm Description
A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system
Intervention Type
Drug
Intervention Name(s)
Vancomycin 1000 MG
Other Intervention Name(s)
antibiotic, vancomycin
Intervention Description
Application of vancomycin in powder in the surgical site of treatment before closure of surgical wound
Primary Outcome Measure Information:
Title
Rate of surgical infection site
Description
Defined as the number of patients with surgical infection site from the total of evaluated patients included in each group.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Patients older than 18 years
Patients with a closed fracture independently of mechanism and classification
Patients who require an open reduction with internal fixation surgery
Patients who decide to participate in the study
Exclusion Criteria:
Patients with exposed fractures
Presence of any form of immune deficiency
Vancomycin hyper sensibility
Surgery in the affected ankle within the last six months
Steroid usage
Antibiotic usage one week prior entry
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Gerardo Garza-Leal, PhD
Phone
528183294000
Ext
2870
Email
investigacionclinical@meduanl.com
Facility Information:
Facility Name
Hospital Universitario "Dr. José E. González"
City
Monterrey
State/Province
NL
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Acosta-Olivo, PhD
Phone
8183467798
Email
dr.carlosacosta@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30545314
Citation
Juto H, Nilsson H, Morberg P. Epidemiology of Adult Ankle Fractures: 1756 cases identified in Norrbotten County during 2009-2013 and classified according to AO/OTA. BMC Musculoskelet Disord. 2018 Dec 13;19(1):441. doi: 10.1186/s12891-018-2326-x.
Results Reference
result
PubMed Identifier
24939377
Citation
Goost H, Wimmer MD, Barg A, Kabir K, Valderrabano V, Burger C. Fractures of the ankle joint: investigation and treatment options. Dtsch Arztebl Int. 2014 May 23;111(21):377-88. doi: 10.3238/arztebl.2014.0377.
Results Reference
result
PubMed Identifier
29443762
Citation
Sun Y, Wang H, Tang Y, Zhao H, Qin S, Xu L, Xia Z, Zhang F. Incidence and risk factors for surgical site infection after open reduction and internal fixation of ankle fracture: A retrospective multicenter study. Medicine (Baltimore). 2018 Feb;97(7):e9901. doi: 10.1097/MD.0000000000009901.
Results Reference
result
PubMed Identifier
20309522
Citation
Golano P, Vega J, de Leeuw PA, Malagelada F, Manzanares MC, Gotzens V, van Dijk CN. Anatomy of the ankle ligaments: a pictorial essay. Knee Surg Sports Traumatol Arthrosc. 2010 May;18(5):557-69. doi: 10.1007/s00167-010-1100-x. Epub 2010 Mar 23.
Results Reference
result
PubMed Identifier
29413771
Citation
Elsoe R, Ostgaard SE, Larsen P. Population-based epidemiology of 9767 ankle fractures. Foot Ankle Surg. 2018 Feb;24(1):34-39. doi: 10.1016/j.fas.2016.11.002. Epub 2016 Nov 18.
Results Reference
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PubMed Identifier
29929022
Citation
Shao J, Zhang H, Yin B, Li J, Zhu Y, Zhang Y. Risk factors for surgical site infection following operative treatment of ankle fractures: A systematic review and meta-analysis. Int J Surg. 2018 Aug;56:124-132. doi: 10.1016/j.ijsu.2018.06.018. Epub 2018 Jun 18.
Results Reference
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PubMed Identifier
27915053
Citation
Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74. doi: 10.1016/j.jamcollsurg.2016.10.029. Epub 2016 Nov 30. No abstract available.
Results Reference
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PubMed Identifier
25948694
Citation
Gross CE, Green CL, DeOrio JK, Easley M, Adams S, Nunley JA 2nd. Impact of Diabetes on Outcome of Total Ankle Replacement. Foot Ankle Int. 2015 Oct;36(10):1144-9. doi: 10.1177/1071100715585575. Epub 2015 May 6.
Results Reference
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PubMed Identifier
26503187
Citation
Martin ET, Kaye KS, Knott C, Nguyen H, Santarossa M, Evans R, Bertran E, Jaber L. Diabetes and Risk of Surgical Site Infection: A Systematic Review and Meta-analysis. Infect Control Hosp Epidemiol. 2016 Jan;37(1):88-99. doi: 10.1017/ice.2015.249. Epub 2015 Oct 27.
Results Reference
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PubMed Identifier
31522274
Citation
Li S, Rong H, Zhang X, Zhang Z, Wang C, Tan R, Wang Y, Zheng T, Zhu T. Meta-analysis of topical vancomycin powder for microbial profile in spinal surgical site infections. Eur Spine J. 2019 Dec;28(12):2972-2980. doi: 10.1007/s00586-019-06143-6. Epub 2019 Sep 14.
Results Reference
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PubMed Identifier
28708777
Citation
Owen MT, Keener EM, Hyde ZB, Crabtree RM, Hudson PW, Griffin RL, Lowe JA. Intraoperative Topical Antibiotics for Infection Prophylaxis in Pelvic and Acetabular Surgery. J Orthop Trauma. 2017 Nov;31(11):589-594. doi: 10.1097/BOT.0000000000000941.
Results Reference
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Citation
Mallela AN, Abdullah KG, Brandon C, Richardson AG, Lucas TH. Topical Vancomycin Reduces Surgical-Site Infections After Craniotomy: A Prospective, Controlled Study. Neurosurgery. 2018 Oct 1;83(4):761-767. doi: 10.1093/neuros/nyx559.
Results Reference
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Topical Antibiotics in Surgical Site
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