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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Patient Satisfaction
• Surgical Site Infection
• Surgical Wound Infection

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