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

NCT04744961 | Completed

• 1 other identifier: RegionSkane2021
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infection; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between patient characteristics and SCAR-Q scores

  3 months

Study Arms (2)

Surgical site infections

Other: SCAR-Q survey

Normal would healing

Other: SCAR-Q survey

Interventions

SCAR-Q survey OTHER

Telephone survey

Normal would healing; Surgical site infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020.

You may not qualify if:

• Patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of dermatology, Skåne university hospital

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Surgical Wound Infection; Patient Satisfaction

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, M.D, Ph.D

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 9, 2021
• Study Start: February 24, 2021
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

SE (1)