InfectionNCT04134338
Effect of Surgical Wound Infection on Health
An observational study of Infection, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
A surgical site infection (SSI) is an infection that occurs after surgery in the part of the body Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Infection
- What is being tested?
- To evaluate the effect of wound infection on costs
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 29 Oct 2019
- 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 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: women who experienced wound infection
Who may be able to join
- wound who had infection post surgery
Who cannot join
- women who had no infection
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasralainy Hospital
Cairo
Ahmed el lithy, M.D, 01120205000, ahmedellithy75@gmail.com
About this study
Official title: Effect of Surgical Wound Infection on Health of Women
A surgical site infection (SSI) is an infection that occurs after surgery in the part of the body
Read the detailed description
Morbidity and mortality were associated with increase of surgical site infections (SSIs).Besides, it was a financial burden and negatively impact of SSIs on patient quality of life (QoL).
- Conditions
- Infection
- Being tested
- To evaluate the effect of wound infection on costs
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To evaluate the effect of wound infection on costsOther
the degree of costs that is required for trating wound infection
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the effect of surgical site infection on health care cost
how much does it cost for wound infection
Measured: within a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Oct 2018
- Primary completion24 Oct 2019 (estimated)
- Study completion29 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, PhD, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134338
- Sponsor's protocol ID
- surgical wound
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgical Wound Infection on Health of Women
- ClinicalTrials.gov ID
- NCT04134338
- Acronym / sponsor ID
- surgical wound
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Oct 2019 (estimated)
- Study completion
- 29 Oct 2019 (estimated)
- First posted
- 22 Oct 2019 (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.
A surgical site infection (SSI) is an infection that occurs after surgery in the part of the body
Detailed description
Morbidity and mortality were associated with increase of surgical site infections (SSIs).Besides, it was a financial burden and negatively impact of SSIs on patient quality of life (QoL).
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women who experienced wound infection
Key inclusion criteria (1 listed)
- wound who had infection post surgery
Key exclusion criteria (1 listed)
- women who had no infection
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 |
|---|---|---|
| To evaluate the effect of wound infection on coststhe degree of costs that is required for trating wound infection | Other | – |
Primary outcome
What is the effect of surgical site infection on health care cost
Time frame: within a month
how much does it cost for wound infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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.
Mahmoud Alalfy, PhD study chair
Algezeera hospitaland National Research Centre ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Aljazeera Hospital at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 22 Oct 2019. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the effect of surgical site infection on health care cost (time frame: within a month). 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 22 Oct 2019.