Perioperative HyperoxygenationNCT02687217

Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy

A study testing oxygen in people with Perioperative Hyperoxygenation and Wound Infection, run by Lady Hardinge Medical College.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them received no oxygen during the surgical procedure. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Perioperative Hyperoxygenation, Wound Infection
What is being tested?: oxygen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Nov 2011to May 2013
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical diagnosis or Radiological diagnosis of acute appendicitis.
Appendectomy through the Mc Burney incision.

Who cannot join

Patients with chronic obstructive pulmonary diseases.
Immunodeficiency disease.
Patients requiring midline incision.
Patients requiring general anaesthesia after failure of spinal anaesthesia.
Patients requiring higher oxygen in perioperative period.

About this study

Official title: Role of Perioperative Hyperoxygenation in Wound Infection Following Surgery for Acute Appendicitis: A Randomised Controlled Trial.

Read the detailed description

Patient with the diagnosis of acute appendicitis of >15 years of age group, with no comorbidities who presented to surgical emergency in Dr. Ram Manohar Lohia Hospital were considered for the present study.

30 patients who fulfilled the inclusion criteria and who voluntarily consented for the study were randomly allocated to the two groups- Group A (control group) and Group B (study group).

These patients were operated through Mc-Burney incision given in the right lower quadrant.

Both the groups were comparable in their demographic and preoperative profile. The study group was given ≥50% of oxygen intraoperatively and the control group was given no oxygen.

In postoperative period, oxygen was given to group A at the rate of 4 litre/minute (L/min) and group B at the rate of 6 litre/minute (L/min).

The assessment of the wound was done by using ASEPSIS (Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay) score. A score of more than 20 is considered to be infected.

Fever, raised total leucocyte count, positive pus culture, Ultrasound evidence of fluid collections, removal of sutures and duration of hospital stay were also measured for the evaluation of economic implications due to SSI.

Conditions: Perioperative Hyperoxygenation, Wound Infection
Being tested: oxygen
Keywords: PerioperativeHyperoxygenation, Wound Site Infection, Appendicitis
Medical subject headings: Wound Infection, Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oxygenDrug
Hyperoxygenation ≥50% of oxygen by mask(non-rebreathing) was given through out the surgery.
Received 6L/min of oxygen through venturimask upto 2 hours in post operative period.
Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery.

Study groups in NCT02687217
Study group	Role	What they receive
Group A: Control	No intervention	Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
Group B: Test	Experimental	Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively. Receives: Drug: oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

ASEPSIS Score
ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection.
Category of infection:
Total score of 0-10 satisfactory healing; 11-20 disturbance of healing; 21-30 minor wound infection; 31-40 moderate wound infection; > 40 severe wound infection.
Measured: 14 days

Secondary outcomes (2)

Number of Patients Requiring Additional Investigations
Sonography; Pus culture; blood culture; Total Leucocyte Count.
Measured: 14 days
Number of Patients Requiring Additional Treatment
Requirement of antipyretics; increased dose/ duration of antibiotic usage other than standard protocol; need for change to higher antibiotics; requirement of drainage procedures for pus/ wound infections; requirement for additional dressing sessions
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011May 2013

First posted22 Feb 2016 (estimated)
Study startNov 2011
Primary completionMar 2013
Study completionMay 2013

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.
Other trials for Perioperative HyperoxygenationStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02687217
Sponsor's protocol ID: LHMC/ECHR/2014/326
Status last verified: Apr 2016
First submitted: 9 Feb 2016
Last updated: 6 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Perioperative Hyperoxygenation in Wound Infection Following Surgery for Acute Appendicitis: A Randomised Controlled Trial.
ClinicalTrials.gov ID: NCT02687217
Acronym / sponsor ID: LHMC/ECHR/2014/326
Conditions: Perioperative Hyperoxygenation, Wound Infection
Keywords: PerioperativeHyperoxygenation, Wound Site Infection, Appendicitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Lady Hardinge Medical CollegeOther government
Study start: Nov 2011
Primary completion: Mar 2013 (actual)
Study completion: May 2013 (actual)
First posted: 22 Feb 2016 (estimated)
Results: Posted 6 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

30 patients who fulfilled the inclusion criteria and who voluntarily consented for the study were randomly allocated to the two groups- Group A (control group) and Group B (study group).

These patients were operated through Mc-Burney incision given in the right lower quadrant.

Both the groups were comparable in their demographic and preoperative profile. The study group was given ≥50% of oxygen intraoperatively and the control group was given no oxygen.

In postoperative period, oxygen was given to group A at the rate of 4 litre/minute (L/min) and group B at the rate of 6 litre/minute (L/min).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A: Control	No intervention	–Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
Group B: Test	Experimental	Drug: oxygenGroup B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis or Radiological diagnosis of acute appendicitis.
Appendectomy through the Mc Burney incision.

Key exclusion criteria (5 listed)

Patients with chronic obstructive pulmonary diseases.
Immunodeficiency disease.
Patients requiring midline incision.
Patients requiring general anaesthesia after failure of spinal anaesthesia.
Patients requiring higher oxygen in perioperative period.

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
oxygenHyperoxygenation ≥50% of oxygen by mask(non-rebreathing) was given through out the surgery. Received 6L/min of oxygen through venturimask upto 2 hours in post operative period. Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery.	Drug	Group B: Test

Primary outcome

ASEPSIS Score
Time frame: 14 days
ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection. Category of infection: Total score of 0-10 satisfactory healing; 11-20 disturbance of healing; 21-30 minor wound infection; 31-40 moderate wound infection; > 40 severe wound infection.

2 secondary outcomes

Number of Patients Requiring Additional Investigations
Time frame: 14 days
Number of Patients Requiring Additional Treatment
Time frame: 14 days

Results and safety

Results posted to the registry on 6 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Control	30	30
Group B: Test	30	30

Primary outcome: ASEPSIS Score

Time frame: 14 days. Number. Unit: participants

Measure	Group A: Control n = 30	Group B: Test n = 30
Satisfactory healing	30	30
Disturbance of healing	0	0
Minor wound infection	0	0
Moderate wound infection	0	0
Severe wound infection	0	0

Group A: Control vs Group B: Test: p = 0.5, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Control	0 of 30 (0%)	0 of 30 (0%)	Not reported
Group B: Test	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): The study included a small sample size of 60 patients, randomized into equal study group and control group as the time limit restrictions of 12- 15 months as prescribed by the residency programme.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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.

Swati Sattavan, M.S. principal investigator

Lady Hardinge Medical College and Associated Hospitals

Questions about this trial

What is this clinical trial studying?

A study testing oxygen in people with Perioperative Hyperoxygenation and Wound Infection, run by Lady Hardinge Medical College.

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 5 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 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 6 May 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?

ASEPSIS Score (time frame: 14 days). 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 NCT02687217.

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 6 May 2016.