Surgical Site Infection (SSI)NCT07696819
Rationale of Subcutaneous Levofloxacin Infiltration as an Adjunct for Surgical Site Infection Prevention in Emergency Laparotomy
A study testing Levofloxacin in people with Surgical Site Infection (SSI), run by Sylhet M.A.G.Osmani Medical College at 1 site in Bangladesh.
Trial summary
Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection (SSI)
- What is being tested?
- Levofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Aug 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged 18 years and above
- Patients undergoing emergency laparotomy for contaminated surgical pathology
- Patients undergoing emergency laparotomy for dirty/infected surgical pathology
Who cannot join
- Patients with known hypersensitivity to levofloxacin or other fluoroquinolones
- Pregnant women or lactating mothers
- Patients with pre-existing severe renal impairment
- Patients with pre-existing skin infection at the incision site
- Patients requiring re-laparotomy within 48 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sylhet MAG Osmani Medical College Hospital contact
Bangladesh1 site
Sylhet MAG Osmani Medical College
Sylhet, 3100
Pranto Chakroborty, MBBS, +8801735303838, pranto.cby@gmail.com
About this study
Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.
This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management.
This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.
Read the detailed description
Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions, where reported incidence ranges considerably higher than in elective clean surgery. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.
This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management. The infiltration dose is calculated based on wound surface area, using a levofloxacin solution prepared at 5 mg/mL concentration, with total dose kept within standard systemic dosing limits.
Participants will be followed for 30 days postoperatively, with structured wound assessments at postoperative day 3, day 7, and day 30. Wound infections will be classified according to CDC/NHSN criteria as superficial incisional, deep incisional, or organ/space SSI. Where infection is suspected, wound swabs will be sent for microbiological culture and antimicrobial sensitivity testing.
This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.
- Conditions
- Surgical Site Infection (SSI)
- Being tested
- Levofloxacin
- Keywords
- Surgical Site Infection, Emergency Laparotomy, Subcutaneous Infiltration, Levofloxacin
- 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.
LevofloxacinDrug
Levofloxacin solution (5 mg/mL) infiltrated subcutaneously along the wound edges at a dose calculated according to wound surface area (approximately 1 mL/cm²), not exceeding the standard maximum systemic dose, administered immediately prior to skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin Infiltration Group | Experimental | Patients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive subcutaneous infiltration of levofloxacin solution (5 mg/mL) along both wound edges immediately before skin closure, in addition to standard surgical and perioperative management. Receives: Drug: Levofloxacin |
| Standard Care Group | No intervention | Patients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive standard surgical management and perioperative care alone, without subcutaneous levofloxacin infiltration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection (SSI)
Proportion of patients developing surgical site infection within 30 days postoperatively, classified according to CDC/NHSN criteria as superficial incisional, deep incisional, or organ/space SSI, assessed through structured wound examination at postoperative day 3, day 7, and day 30.
Measured: 30 days postoperatively
Secondary outcomes (2)
Type of Surgical Site Infection
Classification of surgical site infections occurring in each group as superficial incisional, deep incisional, or organ/space SSI, per CDC/NHSN criteria.
Measured: 30 days postoperatively
Microbiological Profile of Wound Infections
Organisms isolated from wound swab culture in patients diagnosed with surgical site infection in each group.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: intervention group receiving subcutaneous levofloxacin infiltration prior to skin closure, and control group receiving standard surgical management alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sylhet M.A.G.Osmani Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pranto Chakroborty, Sylhet M.A.G.Osmani Medical College
- Investigators
- Pranto Chakroborty, MBBS, Principal investigator, Sylhet MAG Osmani Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696819
- Sponsor's protocol ID
- SOMCH-RCT-2026-01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale of Subcutaneous Levofloxacin Infiltration as an Adjunct for Surgical Site Infection Prevention in Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT07696819
- Acronym / sponsor ID
- SOMCH-RCT-2026-01
- Conditions
- Surgical Site Infection (SSI)
- Keywords
- Surgical Site Infection, Emergency Laparotomy, Subcutaneous Infiltration, Levofloxacin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sylhet M.A.G.Osmani Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 10 Jul 2026 (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.
Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.
This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management.
This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.
Detailed description
Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty/infected abdominal conditions, where reported incidence ranges considerably higher than in elective clean surgery. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.
This trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management. The infiltration dose is calculated based on wound surface area, using a levofloxacin solution prepared at 5 mg/mL concentration, with total dose kept within standard systemic dosing limits.
Participants will be followed for 30 days postoperatively, with structured wound assessments at postoperative day 3, day 7, and day 30. Wound infections will be classified according to CDC/NHSN criteria as superficial incisional, deep incisional, or organ/space SSI. Where infection is suspected, wound swabs will be sent for microbiological culture and antimicrobial sensitivity testing.
This study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups: intervention group receiving subcutaneous levofloxacin infiltration prior to skin closure, and control group receiving standard surgical management alone.
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin Infiltration Group | Experimental | Drug: LevofloxacinPatients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive subcutaneous infiltration of levofloxacin solution (5 mg/mL) along both wound edges immediately before skin closure, in addition to standard surgical and perioperative management. |
| Standard Care Group | No intervention | –Patients undergoing emergency laparotomy for contaminated or dirty/infected abdominal conditions will receive standard surgical management and perioperative care alone, without subcutaneous levofloxacin infiltration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years and above
- Patients undergoing emergency laparotomy for contaminated surgical pathology
- Patients undergoing emergency laparotomy for dirty/infected surgical pathology
Key exclusion criteria (5 listed)
- Patients with known hypersensitivity to levofloxacin or other fluoroquinolones
- Pregnant women or lactating mothers
- Patients with pre-existing severe renal impairment
- Patients with pre-existing skin infection at the incision site
- Patients requiring re-laparotomy within 48 hours
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 |
|---|---|---|
| LevofloxacinLevofloxacin solution (5 mg/mL) infiltrated subcutaneously along the wound edges at a dose calculated according to wound surface area (approximately 1 mL/cm²), not exceeding the standard maximum systemic dose, administered immediately prior to skin closure. | Drug | Levofloxacin Infiltration Group |
Primary outcome
Incidence of Surgical Site Infection (SSI)
Time frame: 30 days postoperatively
Proportion of patients developing surgical site infection within 30 days postoperatively, classified according to CDC/NHSN criteria as superficial incisional, deep incisional, or organ/space SSI, assessed through structured wound examination at postoperative day 3, day 7, and day 30.
2 secondary outcomes
Type of Surgical Site Infection
Time frame: 30 days postoperatively
Microbiological Profile of Wound Infections
Time frame: 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Sylhet MAG Osmani Medical College Hospital contact
Pranto Chakroborty, MBBS principal investigator
Sylhet MAG Osmani Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin in people with Surgical Site Infection (SSI), run by Sylhet M.A.G.Osmani Medical College at 1 site in Bangladesh.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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 Bangladesh. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pranto Chakroborty, MBBS (+8801735303838, pranto.cby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infection (SSI) (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.