Surgical WoundNCT06028854
Blood Characteristics and Abdominal Emergency Surgery
An observational study of Surgical Wound, run by University of Chile at 2 sites in Chile.
Trial summary
After surgical tissue damage, cellular blood components are involved in tissue repair processes, yet their preoperative characteristics are not considered in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound
- How many people
- 40 participants
- Where
- 2 sitesChile
- Study dates
- 15 Oct 2025to 15 Dec 2027
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acute intrabdominal pathology who requires surgery in the next 24 hours.
Who may be able to join
- Patients between 18 and 65 years of age at surgery.
- Patients with acute intra-abdominal pathology requiring emergency surgery.
- A complete blood count was performed in the emergency department of our center within 24 hours before surgery.
Who cannot join
- Patients who are users of anticoagulation before admission for any reason
- Patients who have had previous hospitalization or surgery in the last 6 months.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Clínico de la Universidad de Chile
Independencia, Santiago Metropolitan, 8380456
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
About this study
Official title: Association Between Preoperative Blood Characteristics and Mortality in Abdominal Emergency Surgeries
After surgical tissue damage, cellular blood components are involved in tissue repair processes, yet their preoperative characteristics are not considered in routine clinical practice.
Read the detailed description
Surgical injuries initiate the recruitment of cellular blood components for tissue repair. Baseline inflammation levels and cellular response to tissue damage are absent from perioperative management algorithms despite their importance in regeneration. This project seeks to examine patients preoperative parameters before surgery and evaluate if there is a correlation with clinical outcomes.
- Conditions
- Surgical Wound
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Neutrophil count | Patients with high neutrophil count in their preoperative complete blood count | |
| Low Neutrophil count | Patients with low neutrophil count in their preoperative complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The number of deceased patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Oct 2025 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Why it stopped: The study was suspended because of difficulties in recruiting participants within the expected timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felipe Maldonado, Study chair, Hospital Clinico de la Universidad de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028854
- Sponsor's protocol ID
- OAIC 1337/23
- Status last verified
- Dec 2024
- First submitted
- 31 Aug 2023
- Last updated
- 30 Dec 2024
- 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 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Blood Characteristics and Mortality in Abdominal Emergency Surgeries
- ClinicalTrials.gov ID
- NCT06028854
- Acronym / sponsor ID
- OAIC 1337/23
- Conditions
- Surgical Wound
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The study was suspended because of difficulties in recruiting participants within the expected timeframe.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 8 Sep 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.
After surgical tissue damage, cellular blood components are involved in tissue repair processes, yet their preoperative characteristics are not considered in routine clinical practice.
Detailed description
Surgical injuries initiate the recruitment of cellular blood components for tissue repair. Baseline inflammation levels and cellular response to tissue damage are absent from perioperative management algorithms despite their importance in regeneration. This project seeks to examine patients preoperative parameters before surgery and evaluate if there is a correlation with clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Neutrophil count | – | –Patients with high neutrophil count in their preoperative complete blood count |
| Low Neutrophil count | – | –Patients with low neutrophil count in their preoperative complete blood count |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute intrabdominal pathology who requires surgery in the next 24 hours.
Key inclusion criteria (3 listed)
- Patients between 18 and 65 years of age at surgery.
- Patients with acute intra-abdominal pathology requiring emergency surgery.
- A complete blood count was performed in the emergency department of our center within 24 hours before surgery.
Key exclusion criteria (2 listed)
- Patients who are users of anticoagulation before admission for any reason
- Patients who have had previous hospitalization or surgery in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 1 year
The number of deceased patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Surgical Wound
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
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.
Felipe Maldonado study chair
Hospital Clinico de la Universidad de Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound, run by University of Chile at 2 sites in Chile.
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 2 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: paused, 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 2 sites in Chile. 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?
Results are not available in the source record.
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?
Death (time frame: 1 year). 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 30 Dec 2024.