Surgical Wound InfectionPhase 4NCT04975945
Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI
A Phase 4 study testing Ceftriaxone Sodium in people with Surgical Wound Infection and Surgical Site Infection, run by The Grant Medical College & Sir J.J. Group of Hospitals at 1 site in India.
Trial summary
The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection, Surgical Site Infection
- What is being tested?
- Ceftriaxone Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2021to Jan 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 18 years
- Patients undergoing open and laparoscopic elective, CDC class I \& II surgeries
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Grant Government Medical College and Sir JJ Hospital
Mumbai, Maharashtra, 400008
About this study
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
The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics
Read the detailed 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.
- Conditions
- Surgical Wound Infection, Surgical Site Infection
- Being tested
- Ceftriaxone Sodium
- Keywords
- Ceftriaxone, Surgical wound infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone SodiumDrug
Intravenous vs local action
| Study group | Role | What they receive |
|---|---|---|
| Local | Experimental | Participants will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline) Receives: Drug: Ceftriaxone Sodium |
| Parenteral | Active comparator | Participants will receive parenteral ceftriaxone (15-20mg/kg) for prolonged duration as per local protocol Receives: Drug: Ceftriaxone Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Organism isolated from wound
Microorganism grown on wound swab - Nominal data
Measured: 1 month
Secondary outcomes (1)
Total duration of hospital stay
Number of days of stay in the hospital - Ratio data (Numerical)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Technical and organisational issues at the center, leading to inability to enrol study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Grant Medical College & Sir J.J. Group of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Parth Bhavesh Gada, The Grant Medical College & Sir J.J. Group of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975945
- Sponsor's protocol ID
- generalsurgery/2021/01
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD will be available after contacting the PI on parthg1895@gmail.com
Publications
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.
PubMed 10196487Akhter 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.
PubMed 27064370Kotisso B, Aseffa A. Surgical wound infection in a teaching hospital in Ethiopia. East Afr Med J. 1998 Jul;75(7):402-5.
PubMed 9803631Young 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.
PubMed 25440122Holtz 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.
PubMed 1524269Patel IH, Kaplan SA. Pharmacokinetic profile of ceftriaxone in man. Am J Med. 1984 Oct 19;77(4C):17-25.
PubMed 6093513
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04975945
- Acronym / sponsor ID
- generalsurgery/2021/01
- Conditions
- Surgical Wound Infection, Surgical Site Infection
- Keywords
- Ceftriaxone, Surgical wound infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technical and organisational issues at the center, leading to inability to enrol study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Grant Medical College & Sir J.J. Group of HospitalsOther government
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 26 Jul 2021 (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.
The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local | Experimental | Drug: Ceftriaxone SodiumParticipants will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline) |
| Parenteral | Active comparator | Drug: Ceftriaxone SodiumParticipants will receive parenteral ceftriaxone (15-20mg/kg) for prolonged duration as per local protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above the age of 18 years
- Patients undergoing open and laparoscopic elective, CDC class I \& II surgeries
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Ceftriaxone SodiumIntravenous vs local action | Drug | Local, Parenteral |
Primary outcome
Incidence of Surgical site infection
Time frame: 1 month
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. Purulent drainage, with or without laboratory confirmation, from the superficial incision. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. 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. 4. Diagnosis of superficial incisional SSI by the surgeon or attending physician
Organism isolated from wound
Time frame: 1 month
Microorganism grown on wound swab - Nominal data
1 secondary outcome
Total duration of hospital stay
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 10196487Mangram 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.
- Background: PubMed 27064370Akhter 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.
- Background: PubMed 9803631Kotisso B, Aseffa A. Surgical wound infection in a teaching hospital in Ethiopia. East Afr Med J. 1998 Jul;75(7):402-5.
- Background: PubMed 25440122Young 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.
- Background: PubMed 1524269Holtz 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.
- Background: PubMed 6093513Patel IH, Kaplan SA. Pharmacokinetic profile of ceftriaxone in man. Am J Med. 1984 Oct 19;77(4C):17-25.
- Individual participant dataSharing planned: Yes. all IPD will be available after contacting the PI on parthg1895@gmail.com
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone Sodium in people with Surgical Wound Infection and Surgical Site Infection, run by The Grant Medical College & Sir J.J. Group of Hospitals at 1 site in India.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical site infection (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT04975945, which also lists 6 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 25 Mar 2025.