Topical Antibiotics in Surgical Site

NCT05363462 | Completed DMC

• 1 other identifier: OR20-00007
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Complication of Surgical Procedure

Keywords

Antibiotic; Surgical site infection; Ankle fractures; Complication

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Study Arms (2)

Ankle fracture surgical treated plus 1 g of topical vancomycin

EXPERIMENTAL

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

Drug: Vancomycin 1000 MG

Ankle fracture surgical treated

ACTIVE COMPARATOR

A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system

Drug: Vancomycin 1000 MG

Interventions

Vancomycin 1000 MG DRUG

Application of vancomycin in powder in the surgical site of treatment before closure of surgical wound

Also known as: antibiotic, vancomycin

Ankle fracture surgical treated; Ankle fracture surgical treated plus 1 g of topical vancomycin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Hospital Universitario "Dr. José E. González"

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (12)

• 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.

  PMID: 30545314 RESULT

• 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.

  PMID: 24939377 RESULT

• 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.

  PMID: 29443762 RESULT

• 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.

  PMID: 20309522 RESULT

• 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.

  PMID: 29413771 RESULT

• 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.

  PMID: 29929022 RESULT

• 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.

  PMID: 27915053 RESULT

• 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.

  PMID: 25948694 RESULT

• 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.

  PMID: 26503187 RESULT

• 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.

  PMID: 31522274 RESULT

• 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.

  PMID: 28708777 RESULT

• 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.

  PMID: 29267955 RESULT

MeSH Terms

Conditions

Surgical Wound Infection; Ankle Fractures

Interventions

Vancomycin; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients involved in the protocol will be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups of treatment with a surgical ankle fracture 1. Surgical treatment 2. Surgical treatment plus 1 g of topical vancomycin

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 6, 2022
• Study Start: January 5, 2022
• Primary Completion: December 21, 2023
• Study Completion: February 12, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)