Open FracturePhase 4NCT07437339
Volume Reduction for Open Fracture Irrigation
A Phase 4 study testing 0.9% Sodium Chloride in people with Open Fracture, run by Inova Health Care Services at 1 site in United States.
Trial summary
The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Fracture
- What is being tested?
- 0.9% Sodium Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 31 Dec 2027
- Phase
- Phase 4
- 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
- Age 18 or older
- Patient diagnosed with a Type I, II, or III open fracture of the appendicular skeleton by a study surgeon
- For the purposes of this study, an open fracture is a fracture associated with a soft tissue wound which may or may not be contiguous with the fracture.
- Open fractures of the carpals, tarsals, metacarpals, metatarsal, and/or phalanges without the involvement of a long bone or the hindfoot will not be considered.
Who cannot join
- Patient is unable to understand Informed Consent and/or HIPAA Authorization Form
- Patient does not speak English
- Patient is pregnant
- Patient is unable or (in the judgment of research personnel) unlikely to attend follow-up visits.
- Patient was previously enrolled in a study which has the same primary outcomes or may influence infection rate or bone healing
- Patient declines to participate in study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inova Health System
Falls Church, Virginia, 22042
Abraham Goch, MD, 516-209-7502, abraham.goch@inova.org
Greg Gaski, MD, (786) 473-8895, greg.gaski@inova.org
About this study
Official title: Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial
The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. After the surgeon has determined a participant's bone has healed, any remaining study visits can be conducted over the phone, email, and/or mail. Participants will not be asked to attend additional clinic visits as part of this study. Researchers will compare two different fluid volume protocols to determine if one results in better fracture and/or wound healing.
Read the detailed description
This study compares the two irrigation protocols for Irrigation and Debridement (I\&D) of open fractures. Open fractures are classified using the Gustilo-Anderson classification criteria, which divides these fractures into Types I, II, and III. The study protocols being compared differ in the volume of normal sterile saline used during the I\&D procedure. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III. Irrigation volumes for Protocol A are based on current practice by orthopedic trauma surgeons at Inova. Volumes in Protocol B are based on the FLOW trial study design.
Hypothesis: Decreased irrigation volumes (Protocol A) during surgical I\&D will be non-inferior to high irrigation volumes (Protocol B) with respect to the development of surgical site infection.
Study Design: This is a bimonthly cluster randomized trial in which the study. When enrollment begins, the first two-month (60-day) period will be randomly assigned to either Protocol A or B. Thereafter, the study treatment in effect allocation will alternate every two months (60 days). Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.
This study design is based on the PREP-IT and PREPARE trials, which were national, multicenter RCTs that compared post-surgical infection rates after using different skin sterilization solutions to prepare surgical sites of open and closed fractures.
Patients will receive the protocol in effect at the time they consent to participate in the study, prior to their I\&D, unless otherwise clinically indicated by their study surgeon while in the operating room (OR). All open fracture patients will be screened for participation in the study during their initial evaluation and admission to the hospital, based on inclusion and exclusion criteria detailed in the study protocol. A member of the study team will discuss the study with patients meeting the appropriate criteria prior to their first I\&D. These patients will either be consented/enrolled or will be screen failed due to lack of consent.
- Conditions
- Open Fracture
- Being tested
- 0.9% Sodium Chloride
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium ChlorideDrug
Also called Normal Sterile Saline, Sterline Saline, Normal Saline, Saline
Sterile 0.9% sodium chloride irrigation administered intraoperatively for the purposes of irrigating open fracture wounds. The volume of sterile 0.9% sodium chloride solution used during irrigation is determine by the arm participants are randomized to and the open fracture classification as determined by the study surgeon in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Irrigation Protocol A | Active comparator | Protocol A sets the volume of irrigation as 1 liter normal sterile saline (0.9% sodium chloride) for Type I and Type II open fractures and 3 liters for Type III open fractures. Open fracture type is determined by the study surgeon in the operating room (OR). Receives: Drug: 0.9% Sodium Chloride |
| Irrigation Protocol B | Active comparator | Protocol B sets irrigation volumes as 3 liters normal sterile saline (0.9% sodium chloride) for Type I open fractures, 6 liters for Type II, and 9 liters for Type III. The fracture type is determined by the study surgeon in the operating room (OR). Receives: Drug: 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures.
Surgical site infection within 90 days of I\&D, per CDC definition. The site of interest for this study is the wound created by the fracture mechanism and the debridement thereof. It does not refer to incisions required solely for fixation.
Measured: 90 days after first irrigation and debridement conducted in the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Open FractureStudies 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
- Model description
- During Irrigation and Debridement of an open fracture, patients will receive an irrigation volume dictated by either Protocol A or B as shown in the figure above. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III. This study will follow bimonthly cluster randomization design in which a cluster is defined as admitted open fracture patients requiring I\&D in the OR within a two-month period. The first two-month period will be randomly assigned to either Protocol A or B and treatment allocation will alternate from that point. Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Military Orthopedic Surgeons
- Responsible party
- Sponsor
- Investigators
- Abraham Goch, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437339
- Sponsor's protocol ID
- INOVA-2025-149
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study taking place at one hospital system. All data analysis is planned to take place in-house and there are currently no established data use agreements for the information to be collected.
Publications
Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry DJ, Harrast J, Derosa GP. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: Part-II, certification examination case mix. J Bone Joint Surg Am. 2006 Mar;88(3):660-7. doi: 10.2106/JBJS.E.01208. No abstract available.
PubMed 16510834Anglen JO. Wound irrigation in musculoskeletal injury. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26. doi: 10.5435/00124635-200107000-00001.
PubMed 11476531Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014 May;42(5):525-9. doi: 10.1016/j.ajic.2014.01.012.
PubMed 24773788Crowley DJ, Kanakaris NK, Giannoudis PV. Irrigation of the wounds in open fractures. J Bone Joint Surg Br. 2007 May;89(5):580-5. doi: 10.1302/0301-620X.89B5.19286.
PubMed 17540739Howard M, Court-Brown CM. Epidemiology and management of open fractures of the lower limb. Br J Hosp Med. 1997 Jun 4-17;57(11):582-7.
PubMed 9307681Peterson L.W. Prophylaxis of wound infection: studies with particular reference to soaps and irrigation. Arch Surg. 1945;50(4):177-183
Zalavras CG, Marcus RE, Levin LS, Patzakis MJ. Management of open fractures and subsequent complications. J Bone Joint Surg Am. 2007 Apr;89(4):884-95. doi: 10.2106/00004623-200704000-00027. No abstract available.
PubMed 17432452Cross WW 3rd, Swiontkowski MF. Treatment principles in the management of open fractures. Indian J Orthop. 2008 Oct;42(4):377-86. doi: 10.4103/0019-5413.43373.
PubMed 19753224FLOW Investigators; Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della Rocca GJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL, Tornetta P 3rd, Tufescu T, Walter S, Guyatt GH. A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med. 2015 Dec 31;373(27):2629-41. doi: 10.1056/NEJMoa1508502. Epub 2015 Oct 8.
PubMed 26448371Petrisor B, Jeray K, Schemitsch E, Hanson B, Sprague S, Sanders D, Bhandari M; FLOW Investigators. Fluid lavage in patients with open fracture wounds (FLOW): an international survey of 984 surgeons. BMC Musculoskelet Disord. 2008 Jan 23;9:7. doi: 10.1186/1471-2474-9-7.
PubMed 18215287Wilkins J, Patzakis M. Choice and duration of antibiotics in open fractures. Orthop Clin North Am. 1991 Jul;22(3):433-7.
PubMed 1852421Nicks BA, Ayello EA, Woo K, Nitzki-George D, Sibbald RG. Acute wound management: revisiting the approach to assessment, irrigation, and closure considerations. Int J Emerg Med. 2010 Aug 27;3(4):399-407. doi: 10.1007/s12245-010-0217-5.
PubMed 21373312Kim PH, Leopold SS. In brief: Gustilo-Anderson classification. [corrected]. Clin Orthop Relat Res. 2012 Nov;470(11):3270-4. doi: 10.1007/s11999-012-2376-6. Epub 2012 May 9. No abstract available.
PubMed 22569719Weiss EA, Oldham G, Lin M, Foster T, Quinn JV. Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trial. BMJ Open. 2013 Jan 16;3(1):e001504. doi: 10.1136/bmjopen-2012-001504.
PubMed 23325896Macario A. What does one minute of operating room time cost? J Clin Anesth. 2010 Jun;22(4):233-6. doi: 10.1016/j.jclinane.2010.02.003. No abstract available.
PubMed 20522350
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial
- ClinicalTrials.gov ID
- NCT07437339
- Acronym / sponsor ID
- INOVA-2025-149
- Conditions
- Open Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Society of Military Orthopedic Surgeons
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 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.
The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. After the surgeon has determined a participant's bone has healed, any remaining study visits can be conducted over the phone, email, and/or mail. Participants will not be asked to attend additional clinic visits as part of this study. Researchers will compare two different fluid volume protocols to determine if one results in better fracture and/or wound healing.
Detailed description
This study compares the two irrigation protocols for Irrigation and Debridement (I\&D) of open fractures. Open fractures are classified using the Gustilo-Anderson classification criteria, which divides these fractures into Types I, II, and III. The study protocols being compared differ in the volume of normal sterile saline used during the I\&D procedure. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III. Irrigation volumes for Protocol A are based on current practice by orthopedic trauma surgeons at Inova. Volumes in Protocol B are based on the FLOW trial study design.
Hypothesis: Decreased irrigation volumes (Protocol A) during surgical I\&D will be non-inferior to high irrigation volumes (Protocol B) with respect to the development of surgical site infection.
Study Design: This is a bimonthly cluster randomized trial in which the study. When enrollment begins, the first two-month (60-day) period will be randomly assigned to either Protocol A or B. Thereafter, the study treatment in effect allocation will alternate every two months (60 days). Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.
This study design is based on the PREP-IT and PREPARE trials, which were national, multicenter RCTs that compared post-surgical infection rates after using different skin sterilization solutions to prepare surgical sites of open and closed fractures.
Patients will receive the protocol in effect at the time they consent to participate in the study, prior to their I\&D, unless otherwise clinically indicated by their study surgeon while in the operating room (OR). All open fracture patients will be screened for participation in the study during their initial evaluation and admission to the hospital, based on inclusion and exclusion criteria detailed in the study protocol. A member of the study team will discuss the study with patients meeting the appropriate criteria prior to their first I\&D. These patients will either be consented/enrolled or will be screen failed due to lack of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During Irrigation and Debridement of an open fracture, patients will receive an irrigation volume dictated by either Protocol A or B as shown in the figure above. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III. This study will follow bimonthly cluster randomization design in which a cluster is defined as admitted open fracture patients requiring I\&D in the OR within a two-month period. The first two-month period will be randomly assigned to either Protocol A or B and treatment allocation will alternate from that point. Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.
| Arm | Type | Receives |
|---|---|---|
| Irrigation Protocol A | Active comparator | Drug: 0.9% Sodium ChlorideProtocol A sets the volume of irrigation as 1 liter normal sterile saline (0.9% sodium chloride) for Type I and Type II open fractures and 3 liters for Type III open fractures. Open fracture type is determined by the study surgeon in the operating room (OR). |
| Irrigation Protocol B | Active comparator | Drug: 0.9% Sodium ChlorideProtocol B sets irrigation volumes as 3 liters normal sterile saline (0.9% sodium chloride) for Type I open fractures, 6 liters for Type II, and 9 liters for Type III. The fracture type is determined by the study surgeon in the operating room (OR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Patient diagnosed with a Type I, II, or III open fracture of the appendicular skeleton by a study surgeon
- For the purposes of this study, an open fracture is a fracture associated with a soft tissue wound which may or may not be contiguous with the fracture.
- Open fractures of the carpals, tarsals, metacarpals, metatarsal, and/or phalanges without the involvement of a long bone or the hindfoot will not be considered.
Key exclusion criteria (6 listed)
- Patient is unable to understand Informed Consent and/or HIPAA Authorization Form
- Patient does not speak English
- Patient is pregnant
- Patient is unable or (in the judgment of research personnel) unlikely to attend follow-up visits.
- Patient was previously enrolled in a study which has the same primary outcomes or may influence infection rate or bone healing
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 |
|---|---|---|
| 0.9% Sodium ChlorideAlso: Normal Sterile Saline, Sterline Saline, Normal Saline, SalineSterile 0.9% sodium chloride irrigation administered intraoperatively for the purposes of irrigating open fracture wounds. The volume of sterile 0.9% sodium chloride solution used during irrigation is determine by the arm participants are randomized to and the open fracture classification as determined by the study surgeon in the operating room. | Drug | Irrigation Protocol A, Irrigation Protocol B |
Primary outcome
Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures.
Time frame: 90 days after first irrigation and debridement conducted in the operating room
Surgical site infection within 90 days of I\&D, per CDC definition. The site of interest for this study is the wound created by the fracture mechanism and the debridement thereof. It does not refer to incisions required solely for fixation.
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 Apr 2026.
- Background: PubMed 16510834Garrett WE Jr, Swiontkowski MF, Weinstein JN, Callaghan J, Rosier RN, Berry DJ, Harrast J, Derosa GP. American Board of Orthopaedic Surgery Practice of the Orthopaedic Surgeon: Part-II, certification examination case mix. J Bone Joint Surg Am. 2006 Mar;88(3):660-7. doi: 10.2106/JBJS.E.01208. No abstract available.
- Background: PubMed 11476531Anglen JO. Wound irrigation in musculoskeletal injury. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26. doi: 10.5435/00124635-200107000-00001.
- Background: PubMed 24773788Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014 May;42(5):525-9. doi: 10.1016/j.ajic.2014.01.012.
- Background: PubMed 17540739Crowley DJ, Kanakaris NK, Giannoudis PV. Irrigation of the wounds in open fractures. J Bone Joint Surg Br. 2007 May;89(5):580-5. doi: 10.1302/0301-620X.89B5.19286.
- Background: PubMed 9307681Howard M, Court-Brown CM. Epidemiology and management of open fractures of the lower limb. Br J Hosp Med. 1997 Jun 4-17;57(11):582-7.
- BackgroundPeterson L.W. Prophylaxis of wound infection: studies with particular reference to soaps and irrigation. Arch Surg. 1945;50(4):177-183
- Background: PubMed 17432452Zalavras CG, Marcus RE, Levin LS, Patzakis MJ. Management of open fractures and subsequent complications. J Bone Joint Surg Am. 2007 Apr;89(4):884-95. doi: 10.2106/00004623-200704000-00027. No abstract available.
- Background: PubMed 19753224Cross WW 3rd, Swiontkowski MF. Treatment principles in the management of open fractures. Indian J Orthop. 2008 Oct;42(4):377-86. doi: 10.4103/0019-5413.43373.
- Background: PubMed 26448371FLOW Investigators; Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della Rocca GJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL, Tornetta P 3rd, Tufescu T, Walter S, Guyatt GH. A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med. 2015 Dec 31;373(27):2629-41. doi: 10.1056/NEJMoa1508502. Epub 2015 Oct 8.
- Background: PubMed 18215287Petrisor B, Jeray K, Schemitsch E, Hanson B, Sprague S, Sanders D, Bhandari M; FLOW Investigators. Fluid lavage in patients with open fracture wounds (FLOW): an international survey of 984 surgeons. BMC Musculoskelet Disord. 2008 Jan 23;9:7. doi: 10.1186/1471-2474-9-7.
- Background: PubMed 1852421Wilkins J, Patzakis M. Choice and duration of antibiotics in open fractures. Orthop Clin North Am. 1991 Jul;22(3):433-7.
- Background: PubMed 21373312Nicks BA, Ayello EA, Woo K, Nitzki-George D, Sibbald RG. Acute wound management: revisiting the approach to assessment, irrigation, and closure considerations. Int J Emerg Med. 2010 Aug 27;3(4):399-407. doi: 10.1007/s12245-010-0217-5.
- Individual participant dataSharing planned: No. This is a pilot study taking place at one hospital system. All data analysis is planned to take place in-house and there are currently no established data use agreements for the information to be collected.
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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.
Abraham Goch, MD principal investigator
Inova Health Care Services
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 0.9% Sodium Chloride in people with Open Fracture, run by Inova Health Care Services at 1 site in United States.
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 4 inclusion and 6 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 13 Apr 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 United States. 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?
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 Abraham Goch, MD ((516) 209-7502, abraham.goch@inova.org), 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) following irrigation and debridement of open fractures. (time frame: 90 days after first irrigation and debridement conducted in the operating room). 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 NCT07437339, which also lists 25 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 13 Apr 2026.