Infection, BacterialNCT06166381
Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction
A study testing Parenteral Antibacterial Agents and Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft in people with Infection, Bacterial, run by University of Duhok at 1 site in Iraq.
Trial summary
An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries [1]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Parenteral Antibacterial Agents and Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteIraq
- Study dates
- 25 Jan 2024to Feb 2025
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ACL injury that interferes with life activities and/or sports
Who cannot join
- Patients for revision surgery of ACL reconstruction
- patients with inflammatory rheumatological disorders
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
College of Medicine/University of Duhok
Duhok, 42001
College Duhok, +9647504502810, is@uod.ac
College OMO Duhok, is@uod.ac
About this study
Official title: Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial
An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries [1]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. With an annual incidence of 68.6 per 100,000 person-years, ACL tears remain a common orthopedic injury [2]. Females are two to eight times more likely to develop ACL tears in sports compared to men who play the same particular sports [3]. Most highly demanding persons and those who develop frequent instability of their knee require reconstructive surgery on the ACL to prevent early degenerative changes in their knees. This is done by completely removing the torn or ruptured ACL and replacement with a piece of tendon or ligament (graft) [4].
Post-operative infection may occur in 0.14-2.6% of ACL reconstruction despite intravenous antibiotics prophylaxis [5,6]. The deep infection results in poor outcomes with pain, stiffness, arthrofibrosis, and articular cartilage degeneration [7,8]. Few studies reported improved outcomes of infection control when the autograft presoaked in vancomycin solution during the preparation process outside the body before being transferred to the knee of the patient [9-13]. Systematic reviews and meta-analysis showed that all the articles discussing the outcome of vancomycin presoaked autograft in ACL reconstruction surgery were case series, observational retrospective, prospective comparative, or case-control studies [14,15]. Randomized control trial (RCT) provides the strongest evidence among the primary research studies to confirm the effectiveness of a new method of treatment [16,17]. To date, there is no available RCT study in this field.
Read the detailed description
Aim This study aims to do RTC research on the role of vancomycin-presoaked autograft in ACL reconstruction to decrease the risk of infection.
Objectives To treat patients undergoing ACL reconstruction surgery by two methods to prevent infection (parenteral antibiotic and combined parenteral antibiotic with vancomycin presoaked autograft). To compare between odds ratio of infection occurrence. To check the superiority of the added vancomycin presoaked method in decreasing the risk of infection.
Methods Study type It will be a randomized controlled clinical trial of superiority type. It will be based on a parallel-group type with an allocation ratio of 1:1.
Study setting The research will be conducted in the orthopedic unit, at Azadi Teaching Hospital, Duhok, Iraq.
Inclusion criteria Patients between the ages of 20 to 45 years, of any sex, with ACL dysfunction and needing ACL reconstruction surgery, will be involved in this research.
Exclusion criteria Patients for revision surgery of ACL reconstruction, inflammatory rheumatological disorders, and refusal to participate in the study.
Interventions The patients will be divided into 2 groups: group one (control) will be those who will receive only parenteral antibiotics at induction of anesthesia and for 5 days after the operation. The second group (trial) will receive parenteral antibiotics combined with soaking the autograft of ACL autograft into the vancomycin solution duration preparation of the graft recipient site.
Outcomes The primary outcome will be the odds of cases developing signs of infection up to 6 months postoperatively. No secondary outcome will be recorded for this study.
Sample size The assumed sample size was calculated by using the G*Power 3.1.9.7 computer software program. A minimum of 288 participants (144 for each group) are required to have an 80% chance of detecting the difference between the groups with a two-sided 95% confidence level (0.05 level of significance) to achieve a difference in the odds ratio of 1.8.
Randomization
The allocation of the participants into the modalities of the treatment will be done by a simple randomization method with an allocation ratio of 1:1. It will be generated by using the website program www.randomization.com.
Statistical analysis The data analysis will be performed by SPSS 23.0. The statistical analysis will include the standard descriptive statistics used to describe the basic descriptive data of the patients. The means and standard deviations (SD) or medians and interquartile ranges were used for the continuous variables, while frequencies and percentages were used for the categorical variables. The comparison between the outcomes of the treatment modalities in both groups will be done by finding the difference between the summary statistics in the Chi-squared test. The difference will be considered statistically significant when the p-value is less than 0.05.
- Conditions
- Infection, Bacterial
- Being tested
- Parenteral Antibacterial Agents, Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft
- Keywords
- Anterior cruciate ligament, reconstruction, infection, vancomycin presoaked graft
- Medical subject headings
- Bacterial Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral Antibacterial AgentsDrug
Also called Ceftriaxone sodium
Parenteral antibiotic (ceftriaxone) 1 g to be given in 3 doses, at induction of anesthesia, 12 hours postoperative, and 24 hours postoperative.
Parenteral Antibacterial Agents plus Vancomycin pre-soaked graftDrug
Also called Ceftriaxone sodium intravenously plus Vancomycin pre-soaked graft
in addition to the parenteral ceftriaxone intravenous injections, the ACL graft will be soaked in the vancomycin solution for 20 minutes when prepared outside the body of patient.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | This group will receive parenteral antibiotics to prevent infection in the surgery. Receives: Drug: Parenteral Antibacterial Agents |
| clinical trial | Experimental | This group will include patients who will receive parenteral antibiotics combined with vancomycin presoaked solution for the graft. Receives: Drug: Parenteral Antibacterial Agents; Drug: Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection
deep infection occurs around the graft of the ACL
Measured: 1st day postoperative upto 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start25 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Duhok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jagar Omar Doski, University of Duhok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166381
- Sponsor's protocol ID
- 123456789
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information will be supplied to other researches on reasonable request.
Publications
Cimino F, Volk BS, Setter D. Anterior cruciate ligament injury: diagnosis, management, and prevention. Am Fam Physician. 2010 Oct 15;82(8):917-22.
PubMed 20949884Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
PubMed 26920430Faryniarz DA, Bhargava M, Lajam C, Attia ET, Hannafin JA. Quantitation of estrogen receptors and relaxin binding in human anterior cruciate ligament fibroblasts. In Vitro Cell Dev Biol Anim. 2006 Jul-Aug;42(7):176-81. doi: 10.1290/0512089.1.
PubMed 16948498Bansal A, Lamplot JD, VandenBerg J, Brophy RH. Meta-analysis of the Risk of Infections After Anterior Cruciate Ligament Reconstruction by Graft Type. Am J Sports Med. 2018 May;46(6):1500-1508. doi: 10.1177/0363546517714450. Epub 2017 Jul 24.
PubMed 28737955Maletis GB, Inacio MC, Reynolds S, Desmond JL, Maletis MM, Funahashi TT. Incidence of postoperative anterior cruciate ligament reconstruction infections: graft choice makes a difference. Am J Sports Med. 2013 Aug;41(8):1780-5. doi: 10.1177/0363546513490665. Epub 2013 Jun 7.
PubMed 23749343Schub DL, Schmitz LM, Sakamoto FA, Winalski CS, Parker RD. Long-term outcomes of postoperative septic arthritis after anterior cruciate ligament reconstruction. Am J Sports Med. 2012 Dec;40(12):2764-70. doi: 10.1177/0363546512461903. Epub 2012 Oct 19.
PubMed 23087081Stucken C, Garras DN, Shaner JL, Cohen SB. Infections in anterior cruciate ligament reconstruction. Sports Health. 2013 Nov;5(6):553-7. doi: 10.1177/1941738113489099.
PubMed 24427432Vertullo CJ, Quick M, Jones A, Grayson JE. A surgical technique using presoaked vancomycin hamstring grafts to decrease the risk of infection after anterior cruciate ligament reconstruction. Arthroscopy. 2012 Mar;28(3):337-42. doi: 10.1016/j.arthro.2011.08.301. Epub 2011 Nov 23.
PubMed 22112612Perez-Prieto D, Torres-Claramunt R, Gelber PE, Shehata TMA, Pelfort X, Monllau JC. Autograft soaking in vancomycin reduces the risk of infection after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2724-2728. doi: 10.1007/s00167-014-3438-y. Epub 2014 Nov 22.
PubMed 25416672Phegan M, Grayson JE, Vertullo CJ. No infections in 1300 anterior cruciate ligament reconstructions with vancomycin pre-soaking of hamstring grafts. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2729-2735. doi: 10.1007/s00167-015-3558-z. Epub 2015 Mar 14.
PubMed 25771788Carrozzo A, Saithna A, Ferreira A, Guy S, Chadli L, Monaco E, Perez-Prieto D, Bohu Y, Vieira TD, Sonnery-Cottet B. Presoaking ACL Grafts in Vancomycin Decreases the Frequency of Postoperative Septic Arthritis: A Cohort Study of 29,659 Patients, Systematic Review, and Meta-analysis From the SANTI Study Group. Orthop J Sports Med. 2022 Feb 7;10(2):23259671211073928. doi: 10.1177/23259671211073928. eCollection 2022 Feb.
PubMed 35155711Bohu Y, Klouche S, Sezer HB, Herman S, Grimaud O, Gerometta A, Meyer A, Lefevre N. Vancomycin-soaked autografts during ACL reconstruction reduce the risk of post-operative infection without affecting return to sport or knee function. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2578-2585. doi: 10.1007/s00167-020-05879-9. Epub 2020 Feb 5.
PubMed 32025764Hu M, Zhang Y, Shang G, Guo J, Xu H, Ma X, Yang X, Xiang S. Vancomycin presoak reduces infection in anterior cruciate ligament reconstruction: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2023 Apr 5;24(1):267. doi: 10.1186/s12891-023-06331-y.
PubMed 37020216Rodriguez-Merchan EC, Ribbans WJ. The role of vancomycin-soaking of the graft in anterior cruciate ligament reconstruction. J ISAKOS. 2022 Apr;7(2):94-98. doi: 10.1016/j.jisako.2021.12.006. Epub 2022 Jan 7.
PubMed 35546439Murad MH, Asi N, Alsawas M, Alahdab F. New evidence pyramid. Evid Based Med. 2016 Aug;21(4):125-7. doi: 10.1136/ebmed-2016-110401. Epub 2016 Jun 23.
PubMed 27339128
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06166381
- Acronym / sponsor ID
- 123456789
- Conditions
- Infection, Bacterial
- Keywords
- Anterior cruciate ligament, reconstruction, infection, vancomycin presoaked graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of DuhokUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 12 Dec 2023 (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.
An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries [1]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. With an annual incidence of 68.6 per 100,000 person-years, ACL tears remain a common orthopedic injury [2]. Females are two to eight times more likely to develop ACL tears in sports compared to men who play the same particular sports [3]. Most highly demanding persons and those who develop frequent instability of their knee require reconstructive surgery on the ACL to prevent early degenerative changes in their knees. This is done by completely removing the torn or ruptured ACL and replacement with a piece of tendon or ligament (graft) [4].
Post-operative infection may occur in 0.14-2.6% of ACL reconstruction despite intravenous antibiotics prophylaxis [5,6]. The deep infection results in poor outcomes with pain, stiffness, arthrofibrosis, and articular cartilage degeneration [7,8]. Few studies reported improved outcomes of infection control when the autograft presoaked in vancomycin solution during the preparation process outside the body before being transferred to the knee of the patient [9-13]. Systematic reviews and meta-analysis showed that all the articles discussing the outcome of vancomycin presoaked autograft in ACL reconstruction surgery were case series, observational retrospective, prospective comparative, or case-control studies [14,15]. Randomized control trial (RCT) provides the strongest evidence among the primary research studies to confirm the effectiveness of a new method of treatment [16,17]. To date, there is no available RCT study in this field.
Detailed description
Aim This study aims to do RTC research on the role of vancomycin-presoaked autograft in ACL reconstruction to decrease the risk of infection.
Objectives To treat patients undergoing ACL reconstruction surgery by two methods to prevent infection (parenteral antibiotic and combined parenteral antibiotic with vancomycin presoaked autograft). To compare between odds ratio of infection occurrence. To check the superiority of the added vancomycin presoaked method in decreasing the risk of infection.
Methods Study type It will be a randomized controlled clinical trial of superiority type. It will be based on a parallel-group type with an allocation ratio of 1:1.
Study setting The research will be conducted in the orthopedic unit, at Azadi Teaching Hospital, Duhok, Iraq.
Inclusion criteria Patients between the ages of 20 to 45 years, of any sex, with ACL dysfunction and needing ACL reconstruction surgery, will be involved in this research.
Exclusion criteria Patients for revision surgery of ACL reconstruction, inflammatory rheumatological disorders, and refusal to participate in the study.
Interventions The patients will be divided into 2 groups: group one (control) will be those who will receive only parenteral antibiotics at induction of anesthesia and for 5 days after the operation. The second group (trial) will receive parenteral antibiotics combined with soaking the autograft of ACL autograft into the vancomycin solution duration preparation of the graft recipient site.
Outcomes The primary outcome will be the odds of cases developing signs of infection up to 6 months postoperatively. No secondary outcome will be recorded for this study.
Sample size The assumed sample size was calculated by using the G*Power 3.1.9.7 computer software program. A minimum of 288 participants (144 for each group) are required to have an 80% chance of detecting the difference between the groups with a two-sided 95% confidence level (0.05 level of significance) to achieve a difference in the odds ratio of 1.8.
Randomization
The allocation of the participants into the modalities of the treatment will be done by a simple randomization method with an allocation ratio of 1:1. It will be generated by using the website program www.randomization.com.
Statistical analysis The data analysis will be performed by SPSS 23.0. The statistical analysis will include the standard descriptive statistics used to describe the basic descriptive data of the patients. The means and standard deviations (SD) or medians and interquartile ranges were used for the continuous variables, while frequencies and percentages were used for the categorical variables. The comparison between the outcomes of the treatment modalities in both groups will be done by finding the difference between the summary statistics in the Chi-squared test. The difference will be considered statistically significant when the p-value is less than 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: Parenteral Antibacterial AgentsThis group will receive parenteral antibiotics to prevent infection in the surgery. |
| clinical trial | Experimental | Drug: Parenteral Antibacterial Agents, Drug: Parenteral Antibacterial Agents plus Vancomycin pre-soaked graftThis group will include patients who will receive parenteral antibiotics combined with vancomycin presoaked solution for the graft. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ACL injury that interferes with life activities and/or sports
Key exclusion criteria (3 listed)
- Patients for revision surgery of ACL reconstruction
- patients with inflammatory rheumatological disorders
- Refusal to participate in the study.
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 |
|---|---|---|
| Parenteral Antibacterial AgentsAlso: Ceftriaxone sodiumParenteral antibiotic (ceftriaxone) 1 g to be given in 3 doses, at induction of anesthesia, 12 hours postoperative, and 24 hours postoperative. | Drug | clinical trial, control |
| Parenteral Antibacterial Agents plus Vancomycin pre-soaked graftAlso: Ceftriaxone sodium intravenously plus Vancomycin pre-soaked graftin addition to the parenteral ceftriaxone intravenous injections, the ACL graft will be soaked in the vancomycin solution for 20 minutes when prepared outside the body of patient. | Drug | clinical trial |
Primary outcome
infection
Time frame: 1st day postoperative upto 6 months
deep infection occurs around the graft of the ACL
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 30 Dec 2024.
- Results publication: PubMed 20949884Cimino F, Volk BS, Setter D. Anterior cruciate ligament injury: diagnosis, management, and prevention. Am Fam Physician. 2010 Oct 15;82(8):917-22.
- Results publication: PubMed 26920430Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
- Results publication: PubMed 16948498Faryniarz DA, Bhargava M, Lajam C, Attia ET, Hannafin JA. Quantitation of estrogen receptors and relaxin binding in human anterior cruciate ligament fibroblasts. In Vitro Cell Dev Biol Anim. 2006 Jul-Aug;42(7):176-81. doi: 10.1290/0512089.1.
- Results publication: PubMed 28737955Bansal A, Lamplot JD, VandenBerg J, Brophy RH. Meta-analysis of the Risk of Infections After Anterior Cruciate Ligament Reconstruction by Graft Type. Am J Sports Med. 2018 May;46(6):1500-1508. doi: 10.1177/0363546517714450. Epub 2017 Jul 24.
- Results publication: PubMed 23749343Maletis GB, Inacio MC, Reynolds S, Desmond JL, Maletis MM, Funahashi TT. Incidence of postoperative anterior cruciate ligament reconstruction infections: graft choice makes a difference. Am J Sports Med. 2013 Aug;41(8):1780-5. doi: 10.1177/0363546513490665. Epub 2013 Jun 7.
- Results publication: PubMed 23087081Schub DL, Schmitz LM, Sakamoto FA, Winalski CS, Parker RD. Long-term outcomes of postoperative septic arthritis after anterior cruciate ligament reconstruction. Am J Sports Med. 2012 Dec;40(12):2764-70. doi: 10.1177/0363546512461903. Epub 2012 Oct 19.
- Results publication: PubMed 24427432Stucken C, Garras DN, Shaner JL, Cohen SB. Infections in anterior cruciate ligament reconstruction. Sports Health. 2013 Nov;5(6):553-7. doi: 10.1177/1941738113489099.
- Results publication: PubMed 22112612Vertullo CJ, Quick M, Jones A, Grayson JE. A surgical technique using presoaked vancomycin hamstring grafts to decrease the risk of infection after anterior cruciate ligament reconstruction. Arthroscopy. 2012 Mar;28(3):337-42. doi: 10.1016/j.arthro.2011.08.301. Epub 2011 Nov 23.
- Results publication: PubMed 25416672Perez-Prieto D, Torres-Claramunt R, Gelber PE, Shehata TMA, Pelfort X, Monllau JC. Autograft soaking in vancomycin reduces the risk of infection after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2724-2728. doi: 10.1007/s00167-014-3438-y. Epub 2014 Nov 22.
- Results publication: PubMed 25771788Phegan M, Grayson JE, Vertullo CJ. No infections in 1300 anterior cruciate ligament reconstructions with vancomycin pre-soaking of hamstring grafts. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2729-2735. doi: 10.1007/s00167-015-3558-z. Epub 2015 Mar 14.
- Results publication: PubMed 35155711Carrozzo A, Saithna A, Ferreira A, Guy S, Chadli L, Monaco E, Perez-Prieto D, Bohu Y, Vieira TD, Sonnery-Cottet B. Presoaking ACL Grafts in Vancomycin Decreases the Frequency of Postoperative Septic Arthritis: A Cohort Study of 29,659 Patients, Systematic Review, and Meta-analysis From the SANTI Study Group. Orthop J Sports Med. 2022 Feb 7;10(2):23259671211073928. doi: 10.1177/23259671211073928. eCollection 2022 Feb.
- Results publication: PubMed 32025764Bohu Y, Klouche S, Sezer HB, Herman S, Grimaud O, Gerometta A, Meyer A, Lefevre N. Vancomycin-soaked autografts during ACL reconstruction reduce the risk of post-operative infection without affecting return to sport or knee function. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2578-2585. doi: 10.1007/s00167-020-05879-9. Epub 2020 Feb 5.
- Individual participant dataSharing planned: Yes. The information will be supplied to other researches on reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral Antibacterial Agents and Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft in people with Infection, Bacterial, run by University of Duhok at 1 site in Iraq.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. 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 Iraq. 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 Jagar O Doski (07504594137, jager.doski@uod.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection (time frame: 1st day postoperative upto 6 months). 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 NCT06166381, which also lists 16 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 30 Dec 2024.