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Technical and organisational issues at the center, leading to inability to enrol study participants
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The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local | Experimental | Participants will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline) |
|
| Parenteral | Active Comparator | Participants will receive parenteral ceftriaxone (15-20mg/kg) for prolonged duration as per local protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxone Sodium | Drug | Intravenous vs local action |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 month |
| Organism isolated from wound | Microorganism grown on wound swab - Nominal data | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of hospital stay | Number of days of stay in the hospital - Ratio data (Numerical) | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grant Government Medical College and Sir JJ Hospital | Mumbai | Maharashtra | 400008 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10196487 | Background | 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. | |
| 27064370 | Background |
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all IPD will be available after contacting the PI on parthg1895@gmail.com
Will be available on completion of the study
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| 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. |
| 9803631 | Background | Kotisso B, Aseffa A. Surgical wound infection in a teaching hospital in Ethiopia. East Afr Med J. 1998 Jul;75(7):402-5. |
| 25440122 | Background | 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. |
| 1524269 | Background | 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. doi: 10.1016/s0196-6553(05)80148-8. |
| 6093513 | Background | Patel IH, Kaplan SA. Pharmacokinetic profile of ceftriaxone in man. Am J Med. 1984 Oct 19;77(4C):17-25. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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