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NCT04744961 Clinical Trial

Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery

Surgical Site Infection Clinical Trial

Official title:
Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04744961
Other study ID # RegionSkane2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 24, 2021
Est. completion date May 17, 2021

Study information
Verified date May 2021
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date May 17, 2021
Est. primary completion date May 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020. Exclusion Criteria: - Patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SCAR-Q survey
Telephone survey

Locations
Country Name City State
Sweden Department of dermatology, Skåne university hospital Lund

Sponsors (1)
Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary 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) 3 months
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