Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI

Surgical Site Infection Clinical Trial

Official title:

A Randomized Controlled Study Assessing Prolonged Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration in Elective Clean and Clean-contaminated Surgeries for Prevention of Surgical Site Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975945
• Other study ID #: generalsurgery/2021/01
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2021
• Est. completion date: January 2022

Study information

• Verified date: July 2021
• Source: The Grant Medical College & Sir J.J. Group of Hospitals
• Contact: Parth B Gada
• Phone: +919769888446
• Email: parthg1895[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics

Description:

Patients undergoing above 18 years of age, giving consent and undergoing open or laparoscopic elective, CDC class I & II surgeries will be recruited. Cases will be randomised into two cohorts viz: parenteral antibiotic (Group A) vs single-time intra-operative intra-dermal antibiotic administration group (Group B). In operation theatre, after induction of anaesthesia, Group A will receive parenteral ceftriaxone (15-20mg/kg) whereas Group B will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline). Post-operatively, incision site will be covered with occlusive dressing. First check-dressing will be done after 48 hours as per the existing institutional practices. After that surgical site will be inspected daily for wound infection. Patients with healthy wound will be discharged at the discretion of the treating surgeon and will be asked to follow up in General Surgery OPD weekly for one month. Cases who developed an SSI will have samples collected from the afflicted area for bacterial culture and antibiotic susceptibility testing. On development of SSI, the treating clinical team will commence antibiotic therapy as per their protocols.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients above the age of 18 years

• Patients undergoing open and laparoscopic elective, CDC class I & II surgeries

Exclusion Criteria:

• Patients exhibiting hypersensitivity reaction to ceftriaxone

• Patients who are immunocompromised (retroviral disease and corticosteroid use)

• Patients not consenting to be a part of this study

• Pregnancy

• Febrile illness or leucocytosis at the time of surgery

• Planned for staged/multiple interventions during the hospital stay (endoscopies, image-guided biopsies etc)

• Patients with a possible septic focus distant from the surgical site such as diabetic foot ulcers.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Ceftriaxone Sodium
Intravenous vs local action

Locations

Country	Name	City	State
India	Grant Government Medical College and Sir JJ Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
The Grant Medical College & Sir J.J. Group of Hospitals

Country where clinical trial is conducted

India, 

References & Publications (6)

Akhter MS, Verma R, Madhukar KP, Vaishampayan AR, Unadkat PC. Incidence of surgical site infection in postoperative patients at a tertiary care centre in India. J Wound Care. 2016 Apr;25(4):210-2, 214-7. doi: 10.12968/jowc.2016.25.4.210. — View Citation

Holtz TH, Wenzel RP. Postdischarge surveillance for nosocomial wound infection: a brief review and commentary. Am J Infect Control. 1992 Aug;20(4):206-13. Review. — View Citation

Kotisso B, Aseffa A. Surgical wound infection in a teaching hospital in Ethiopia. East Afr Med J. 1998 Jul;75(7):402-5. — View Citation

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96. — View Citation

Patel IH, Kaplan SA. Pharmacokinetic profile of ceftriaxone in man. Am J Med. 1984 Oct 19;77(4C):17-25. Review. — View Citation

Young PY, Khadaroo RG. Surgical site infections. Surg Clin North Am. 2014 Dec;94(6):1245-64. doi: 10.1016/j.suc.2014.08.008. Epub 2014 Oct 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Surgical site infection	Infection occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the following: Purulent drainage, with or without laboratory confirmation, from the superficial incision.; Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.; At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless the incision is culture-negative.; Diagnosis of superficial incisional SSI by the surgeon or attending physician	1 month
Primary	Organism isolated from wound	Microorganism grown on wound swab - Nominal data	1 month
Secondary	Total duration of hospital stay	Number of days of stay in the hospital - Ratio data (Numerical)	1 month