Surgical Site InfectionPhase 4PORSSINCT00876005
Supplemental Oxygen and the Risk of Surgical Site Infection
A Phase 4 study testing Oxygen by mask in people with Surgical Site Infection, run by Santa Clara Valley Health & Hospital System at 1 site in United States.
Trial summary
This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Oxygen by mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,202 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Apr 2011
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mentally competent patients undergoing cesarean section under spinal or epidural anesthesia
Who cannot join
- fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa clara Valley Medical Center
San Jose, California, 95128
About this study
Official title: Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection
This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.
Read the detailed description
This is a double-blinded prospective randomized,controlled trial to evaluate whether using a higher concentration of oxygen during and after surgery helps to decrease the wound infection rate in patients undergoing cesarean sections.
- Conditions
- Surgical Site Infection
- Being tested
- Oxygen by mask
- Keywords
- Wound infection
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen by maskOther
Also called Face mask delivery of supplemental oxygen at 80%
Postoperatively, an aerosol face mask is used to deliver oxygen at 80%
Oxygen by maskOther
Also called face mask delivery of supplemental oxygen at 30%
Postoperatively, an aerosol face mask is used to deliver oxygen at 30%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 80% oxygen during cesarean section Receives: Other: Oxygen by mask |
| 2 | Active comparator | 30% oxygen during cesarean section Receives: Other: Oxygen by mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startAug 2006
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Clara Valley Health & Hospital System
- Sponsor type
- University, hospital or other
- Investigators
- Neena Duggal, MD, Principal investigator, Santa Clara Valley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876005
- Sponsor's protocol ID
- 5/11/07-04
- Acronym
- PORSSI
- Status last verified
- May 2016
- First submitted
- 3 Apr 2009
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duggal N, Poddatorri V, Noroozkhani S, Siddik-Ahmad RI, Caughey AB. Perioperative oxygen supplementation and surgical site infection after cesarean delivery: a randomized trial. Obstet Gynecol. 2013 Jul;122(1):79-84. doi: 10.1097/AOG.0b013e318297ec6c.
PubMed 23743467
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection
- ClinicalTrials.gov ID
- NCT00876005
- Acronym / sponsor ID
- PORSSI / 5/11/07-04
- Conditions
- Surgical Site Infection
- Keywords
- Wound infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,202 participants (estimated)
- Lead sponsor
- Santa Clara Valley Health & Hospital SystemUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Apr 2009 (estimated)
- 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 is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.
Detailed description
This is a double-blinded prospective randomized,controlled trial to evaluate whether using a higher concentration of oxygen during and after surgery helps to decrease the wound infection rate in patients undergoing cesarean sections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Oxygen by mask80% oxygen during cesarean section |
| 2 | Active comparator | Other: Oxygen by mask30% oxygen during cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mentally competent patients undergoing cesarean section under spinal or epidural anesthesia
Key exclusion criteria (1 listed)
- fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section
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 |
|---|---|---|
| Oxygen by maskAlso: Face mask delivery of supplemental oxygen at 80%Postoperatively, an aerosol face mask is used to deliver oxygen at 80% | Other | 1 |
| Oxygen by maskAlso: face mask delivery of supplemental oxygen at 30%Postoperatively, an aerosol face mask is used to deliver oxygen at 30% | Other | 2 |
Primary outcome
Surgical site infection
Time frame: 2 weeks
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 13 Oct 2016.
- Derived from this study: PubMed 23743467Duggal N, Poddatorri V, Noroozkhani S, Siddik-Ahmad RI, Caughey AB. Perioperative oxygen supplementation and surgical site infection after cesarean delivery: a randomized trial. Obstet Gynecol. 2013 Jul;122(1):79-84. doi: 10.1097/AOG.0b013e318297ec6c.
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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.
Neena Duggal, MD principal investigator
Santa Clara Valley Medical Center
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 Oxygen by mask in people with Surgical Site Infection, run by Santa Clara Valley Health & Hospital System 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 1 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 13 Oct 2016. 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?
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?
Surgical site infection (time frame: 2 weeks). 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 NCT00876005, 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 13 Oct 2016.