Surgical Site InfectionNCT04744961
Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery
An observational study of Surgical Site Infection and Patient Satisfaction, run by Region Skane at 1 site in Sweden.
Trial summary
This study involves surveying two matched groups of patients that underwent dermatologic surgery at our department. One group had a documented surgical site infection and the other didn't. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Patient Satisfaction
- What is being tested?
- SCAR-Q survey
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- 24 Feb 2021to 17 May 2021
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All included patients had a surgical procedure performed at our department. One group had documented surgical site infections and the other didn't.
Who may be able to join
- Patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020.
Who cannot join
- Patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
This study involves surveying two matched groups of patients that underwent dermatologic surgery at our department. One group had a documented surgical site infection and the other didn't. All patients will be asked to complete a questionnaire in which they assess the physical appearance of their scars and its psychosocial impact. Results will be compared between the groups.
Read the detailed description
65 patients with a documented surgical site infection will be compared to 65 patients with normal wound healing in terms of patient reported outcome regarding scar physical appearance and psychosocial impact using SCAR-Q questionnaire.
- Conditions
- Surgical Site Infection, Patient Satisfaction
- Being tested
- SCAR-Q survey
- Medical subject headings
- Surgical Wound Infection, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCAR-Q surveyOther
Telephone survey
| Study group | Role | What they receive |
|---|---|---|
| Surgical site infections | Not described Receives: Other: SCAR-Q survey | |
| Normal would healing | Not described Receives: Other: SCAR-Q survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing mean values of SCAR-Q scores in both groups
Scar-Q (http://qportfolio.org/scar-q/) is a patient reported outcome instrument in which scars will be assessed in terms of scar appearance and psychosocial impact. Scores will range from 0 (worst) to 100 (best). Scores will be compared between the two groups using either parametric or non-parametric tests depending on the distribution of the results.
Measured: 3 months
Secondary outcomes (1)
Association between patient characteristics and SCAR-Q scores
Score values (0-100) will be correlated to the following patient characteristics (gender, age, type of surgical procedure, anatomic location, and diagnosis of excised lesion)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start24 Feb 2021
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Saleh, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744961
- Sponsor's protocol ID
- RegionSkane2021
- Status last verified
- May 2021
- First submitted
- 3 Feb 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery
- ClinicalTrials.gov ID
- NCT04744961
- Acronym / sponsor ID
- RegionSkane2021
- Conditions
- Surgical Site Infection, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 9 Feb 2021 (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.
This study involves surveying two matched groups of patients that underwent dermatologic surgery at our department. One group had a documented surgical site infection and the other didn't. All patients will be asked to complete a questionnaire in which they assess the physical appearance of their scars and its psychosocial impact. Results will be compared between the groups.
Detailed description
65 patients with a documented surgical site infection will be compared to 65 patients with normal wound healing in terms of patient reported outcome regarding scar physical appearance and psychosocial impact using SCAR-Q questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical site infections | – | Other: SCAR-Q survey |
| Normal would healing | – | Other: SCAR-Q survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All included patients had a surgical procedure performed at our department. One group had documented surgical site infections and the other didn't.
Key inclusion criteria (1 listed)
- Patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020.
Key exclusion criteria (1 listed)
- Patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment
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 |
|---|---|---|
| SCAR-Q surveyTelephone survey | Other | Normal would healing, Surgical site infections |
Primary outcome
Comparing mean values of SCAR-Q scores in both groups
Time frame: 3 months
Scar-Q (http://qportfolio.org/scar-q/) is a patient reported outcome instrument in which scars will be assessed in terms of scar appearance and psychosocial impact. Scores will range from 0 (worst) to 100 (best). Scores will be compared between the two groups using either parametric or non-parametric tests depending on the distribution of the results.
1 secondary outcome
Association between patient characteristics and SCAR-Q scores
Time frame: 3 months
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 18 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgical Site Infection and Patient Satisfaction, run by Region Skane at 1 site in Sweden.
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 18 May 2021. 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 Sweden. 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?
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?
Comparing mean values of SCAR-Q scores in both groups (time frame: 3 months). 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 18 May 2021.