Wound InfectionNCT00235456
Supplemental Oxygen Reduces Surgical Infection
A study testing Perioperative supplemental oxygen and Standard oxygen in people with Wound Infection, run by The Cleveland Clinic at 1 site in Spain.
Trial summary
Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- Perioperative supplemental oxygen and Standard oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2003to Jan 2005
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective colorectal resection,
- Patients having abdominal-peritoneal reconstructions were included, but not those scheduled for minor colon surgery (e.g., polypectomy, isolated colostomy) or laparoscopic surgery.
Who cannot join
- Exclusion criteria included expected surgery time of less than one hour, fever or existing signs of infection, diabetes mellitus (type I or II), HIV infection, weight loss exceeding 20% in the previous three months, serum albumin concentration < 30 g/L, and a leukocyte count <2500 cells/ml.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial
Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.
Read the detailed description
Context: Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection.
Objective: We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery.
Design: Randomized, controlled trial. Setting: Fourteen Spanish hospitals. Patients: Three hundred patients undergoing elective colorectal surgery. Interventions: Patients were randomly assigned to either 30% or 80% FiO2 intraoperatively and for 6 hours after surgery. Anesthetic management and antibiotic administration were standardized.
Main outcome measures: Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. The wound infection rate in the 30% and 80% oxygen groups was compared with chi-square analysis. A logistic regression was used to identify the contribution of potential confounding factors.
- Conditions
- Wound Infection
- Being tested
- Perioperative supplemental oxygen, Standard oxygen
- Keywords
- oxygen, surgical complications, colo-rectal resections
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative supplemental oxygenProcedure or surgery
Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygenProcedure or surgery
Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
| Study group | Role | What they receive |
|---|---|---|
| 80% perioperative oxygen | Active comparator | Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Receives: Procedure: Perioperative supplemental oxygen |
| 30% perioperative oxygen | Placebo comparator | Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Receives: Procedure: Standard oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Surgical Wound Infection
Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.
Measured: 0 to 14 days after surgery
Secondary outcomes (5)
Return of Bowel Function
Time to return of bowel function, measured in days.
Measured: time to event after surgery to discharge from hospital
Return to Ambulation
time to return to ambulation after surgery, measured in days
Measured: time to event after surgery
First Solid Food Intake
Time to restarting feeding after surgery, measured in days.
Measured: time to event after surgery
Staples Removed
Time to staples removed, measured in days
Measured: time to event after surgery
Hospital Length of Stay
The number of days patient stayed in the hospital after surgery.
Measured: time to hospital discharge after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startMar 2003
- Primary completionOct 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, d sessler, The Cleveland Clinic
- Investigators
- F. Javier Belda, MD, PhD, Study director, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235456
- Sponsor's protocol ID
- RETIQ
- Status last verified
- Dec 2016
- First submitted
- 6 Oct 2005
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.
PubMed 16249417
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial
- ClinicalTrials.gov ID
- NCT00235456
- Acronym / sponsor ID
- RETIQ
- Conditions
- Wound Infection
- Keywords
- oxygen, surgical complications, colo-rectal resections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Posted 29 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.
Detailed description
Context: Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection.
Objective: We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery.
Design: Randomized, controlled trial. Setting: Fourteen Spanish hospitals. Patients: Three hundred patients undergoing elective colorectal surgery. Interventions: Patients were randomly assigned to either 30% or 80% FiO2 intraoperatively and for 6 hours after surgery. Anesthetic management and antibiotic administration were standardized.
Main outcome measures: Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. The wound infection rate in the 30% and 80% oxygen groups was compared with chi-square analysis. A logistic regression was used to identify the contribution of potential confounding factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80% perioperative oxygen | Active comparator | Procedure: Perioperative supplemental oxygenPerioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
| 30% perioperative oxygen | Placebo comparator | Procedure: Standard oxygenStandard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective colorectal resection,
- Patients having abdominal-peritoneal reconstructions were included, but not those scheduled for minor colon surgery (e.g., polypectomy, isolated colostomy) or laparoscopic surgery.
Key exclusion criteria (1 listed)
- Exclusion criteria included expected surgery time of less than one hour, fever or existing signs of infection, diabetes mellitus (type I or II), HIV infection, weight loss exceeding 20% in the previous three months, serum albumin concentration < 30 g/L, and a leukocyte count <2500 cells/ml.
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 |
|---|---|---|
| Perioperative supplemental oxygenPatients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. | Procedure or surgery | 80% perioperative oxygen |
| Standard oxygenPatients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. | Procedure or surgery | 30% perioperative oxygen |
Primary outcome
Incisional Surgical Wound Infection
Time frame: 0 to 14 days after surgery
Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.
5 secondary outcomes
Return of Bowel Function
Time frame: time to event after surgery to discharge from hospital
Return to Ambulation
Time frame: time to event after surgery
First Solid Food Intake
Time frame: time to event after surgery
Staples Removed
Time frame: time to event after surgery
Hospital Length of Stay
Time frame: time to hospital discharge after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16249417Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.
- 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. This study is not recruiting at the moment.
F. Javier Belda, MD, PhD study director
Hospital Clínico Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative supplemental oxygen and Standard oxygen in people with Wound Infection, run by The Cleveland Clinic at 1 site in Spain.
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 1 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 10 Feb 2017. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incisional Surgical Wound Infection (time frame: 0 to 14 days after surgery). 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 NCT00235456, which also lists 1 linked publication.
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 10 Feb 2017.