Surgical Site Infection (SSI)Phase 3NCT07866157
Efficacy of Intrawound Vancomycin in Spine Surgery
A Phase 3 study testing vancomycin and Standard surgical closure in people with Surgical Site Infection (SSI) and Spine Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
"This multicenter, prospective, time-cluster randomized controlled trial with blinded endpoint assessment (PROBE design) evaluated the efficacy of intrawound vancomycin powder (2 g) in preventing surgical site infections (SSI) following spine surgeries. Read more about this study
- Who is it for?
- Ages 15 to 78 years
- Conditions the study is for
- Surgical Site Infection (SSI), Spine Diseases
- What is being tested?
- vancomycin and Standard surgical closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2023to 2 Jun 2026
- Phase
- Phase 3
- 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 15 to 78 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients undergoing elective open posterior instrumented spine surgery.
- Patients willing to participate and provide informed consent.
Who cannot join
- Presence of active systemic infection or local infection at the surgical site prior to surgery.
- Known allergy or hypersensitivity to vancomycin.
- Patients undergoing minimally invasive spine surgery (MISS) without formal open exposure.
- Previous history of surgical site infection in the spine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title: Efficacy of Intrawound Vancomycin Powder in Reducing Surgical Site Infections in Spine Surgery: A Multicenter, Time-Cluster Randomized Controlled Trial With Blinded Endpoint Assessment
"This multicenter, prospective, time-cluster randomized controlled trial with blinded endpoint assessment (PROBE design) evaluated the efficacy of intrawound vancomycin powder (2 g) in preventing surgical site infections (SSI) following spine surgeries. The study included 416 patients who were allocated using alternating monthly time-clusters (25 months) to receive either standard care with topical vancomycin or standard care alone (control). The primary endpoint, the incidence of 90-day SSI, was evaluated by blinded clinical assessors to minimize bias."
Read the detailed description
This study was designed to overcome the logistical challenges of individual randomization within operating rooms by utilizing a time-cluster allocation approach. Over a 25-month period, alternating months were designated as either intervention or control clusters. The vancomycin group included 207 patients, and the standard care control group included 209 patients. Baseline demographic and clinical characteristics, including age, sex, smoking status, and diabetes mellitus, were statistically balanced between the two cohorts.
Patients in the active cluster received 2 grams of vancomycin powder applied directly to the subfascial and deep layers prior to wound closure. Patients in the control cluster received standard surgical closure without topical antibiotics. All participants were followed for up to 90 days post-operatively.
To minimize detection bias in this open-label surgical intervention, a Prospective Randomized Open, Blinded End-point (PROBE) design was strictly enforced. All primary and secondary infection outcomes were independently evaluated and diagnosed by clinical assessors who were completely blinded to the patients' cluster allocation and treatment status.
- Conditions
- Surgical Site Infection (SSI), Spine Diseases
- Being tested
- vancomycin, Standard surgical closure
- Keywords
- Intrawound Vancomycin, Topical Antibiotics, Spine Surgery, Surgical Prophylaxis
- Medical subject headings
- Surgical Wound Infection, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycinDrug
Also called vancomycin 2 gram
Application of 2 grams of intrawound vancomycin powder topically to the deep and subfascial layers prior to wound closure.
Standard surgical closureProcedure or surgery
Standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Intrawound Vancomycin Group | Experimental | Patients operated on during the intervention time-clusters received 2 grams of intrawound vancomycin powder applied topically to the deep and subfascial layers prior to wound closure. Receives: Drug: vancomycin |
| Control Group (Standard Care) | Active comparator | Patients operated on during the control time-clusters received standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics. Receives: Procedure: Standard surgical closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
INCIDENCE OF SURGICAL SITE INFECTION (SSI)
The primary outcome is the occurrence of any superficial, deep, or organ/space surgical site infection (SSI) following the index spine surgery. SSI is diagnosed and classified according to the standard criteria set by the Centers for Disease Control and Prevention (CDC).
Measured: UP TO 90 DAYS
Secondary outcomes (2)
Depth of Surgical Site Infection (SSI)
Classification of the surgical site infection according to the depth of tissue involvement (superficial incisional, deep incisional, or organ/space), based on the standard Centers for Disease Control and Prevention (CDC) criteria.
Measured: UP TO 90 DAYS
Microbiological Profile of Surgical Site Infections
Identification of the causative bacterial organisms in patients who develop a surgical site infection (SSI). This includes analyzing the incidence of specific pathogens (e.g., Gram-positive bacteria such as MRSA, and Gram-negative bacteria) isolated from deep wound cultures.
Measured: Up to 90 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start2 Dec 2023
- Primary completion2 May 2026
- Study completion2 Jun 2026
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866157
- Sponsor's protocol ID
- ASU-OrthoSpine-Vanco-2023
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Efficacy of Intrawound Vancomycin Powder in Reducing Surgical Site Infections in Spine Surgery: A Multicenter, Time-Cluster Randomized Controlled Trial With Blinded Endpoint Assessment
- ClinicalTrials.gov ID
- NCT07866157
- Acronym / sponsor ID
- ASU-OrthoSpine-Vanco-2023
- Conditions
- Surgical Site Infection (SSI), Spine Diseases
- Keywords
- Intrawound Vancomycin, Topical Antibiotics, Spine Surgery, Surgical Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 8 Oct 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.
"This multicenter, prospective, time-cluster randomized controlled trial with blinded endpoint assessment (PROBE design) evaluated the efficacy of intrawound vancomycin powder (2 g) in preventing surgical site infections (SSI) following spine surgeries. The study included 416 patients who were allocated using alternating monthly time-clusters (25 months) to receive either standard care with topical vancomycin or standard care alone (control). The primary endpoint, the incidence of 90-day SSI, was evaluated by blinded clinical assessors to minimize bias."
Detailed description
This study was designed to overcome the logistical challenges of individual randomization within operating rooms by utilizing a time-cluster allocation approach. Over a 25-month period, alternating months were designated as either intervention or control clusters. The vancomycin group included 207 patients, and the standard care control group included 209 patients. Baseline demographic and clinical characteristics, including age, sex, smoking status, and diabetes mellitus, were statistically balanced between the two cohorts.
Patients in the active cluster received 2 grams of vancomycin powder applied directly to the subfascial and deep layers prior to wound closure. Patients in the control cluster received standard surgical closure without topical antibiotics. All participants were followed for up to 90 days post-operatively.
To minimize detection bias in this open-label surgical intervention, a Prospective Randomized Open, Blinded End-point (PROBE) design was strictly enforced. All primary and secondary infection outcomes were independently evaluated and diagnosed by clinical assessors who were completely blinded to the patients' cluster allocation and treatment status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrawound Vancomycin Group | Experimental | Drug: vancomycinPatients operated on during the intervention time-clusters received 2 grams of intrawound vancomycin powder applied topically to the deep and subfascial layers prior to wound closure. |
| Control Group (Standard Care) | Active comparator | Procedure: Standard surgical closurePatients operated on during the control time-clusters received standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics. |
Who may qualify
- Ages
- 15 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing elective open posterior instrumented spine surgery.
- Patients willing to participate and provide informed consent.
Key exclusion criteria (4 listed)
- Presence of active systemic infection or local infection at the surgical site prior to surgery.
- Known allergy or hypersensitivity to vancomycin.
- Patients undergoing minimally invasive spine surgery (MISS) without formal open exposure.
- Previous history of surgical site infection in the spine.
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 |
|---|---|---|
| vancomycinAlso: vancomycin 2 gramApplication of 2 grams of intrawound vancomycin powder topically to the deep and subfascial layers prior to wound closure. | Drug | Intrawound Vancomycin Group |
| Standard surgical closureStandard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics. | Procedure or surgery | Control Group (Standard Care) |
Primary outcome
INCIDENCE OF SURGICAL SITE INFECTION (SSI)
Time frame: UP TO 90 DAYS
The primary outcome is the occurrence of any superficial, deep, or organ/space surgical site infection (SSI) following the index spine surgery. SSI is diagnosed and classified according to the standard criteria set by the Centers for Disease Control and Prevention (CDC).
2 secondary outcomes
Depth of Surgical Site Infection (SSI)
Time frame: UP TO 90 DAYS
Microbiological Profile of Surgical Site Infections
Time frame: Up to 90 days post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 3 study testing vancomycin and Standard surgical closure in people with Surgical Site Infection (SSI) and Spine Diseases, run by Ain Shams University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 15 Oct 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (SSI) (time frame: UP TO 90 DAYS). 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 15 Oct 2026.