Investigating the Effects of Orienting Skin Grafts Parallel to Skin Tension Lines on Quality of Life in Head and Neck Located Basal Cell Carcinoma

NCT06894056 | Completed

• 1 other identifier: KAEK258
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the effect of orienting graft for treatment of skin cancer in patients who undergo skin cancer excision and grafting for their skin cancer. The main question to answer is Does orienting the grafts parallel with skin tension lines have any effect on quality of life or cosmetic results? Participants who already underwent or planned to undergo an excision and grafting procedure will answer a qaulity of life tool and cosmetic results will be evaluated by two seperate dermatologist.

Conditions

Basal Cell Cancer; Grafting

Keywords

basal cell carcinoma; skin tension lines; grafting; cosmetic outcome; quality of life

Outcome Measures

Primary Outcomes (2)

• Quality of Life Outcome

  Quality of life outcome was measured by the disease specific tool "Skin Cancer Quality of Life Impact Tool", SCQOLIT is a 10 item questionnaire and each item has 4 answers, total score is ranged between 0-30. Higher scores mean worse outcomes.

  At least three months after surgery and grafting

• Quality of Life - General

  Dermatology Quality of Life Index was also used to evaluate quality of life as a general quality of life tool. DLQI is alsa a ten item tool with a total score range between 0-30. Higher scores mean worse outcomes.

  At least three months after surgery and grafting

Secondary Outcomes (1)

• Cosmetic Outcome

  At least three months after the surgery and grafting

Study Arms (2)

Group 1

Control patients were selected either from patients with head and neck located BCC's who were treated with excision with grafting harvested from clavicular region with no specific attention in terms of orientation of skin tension lines

Group 2

Group two was selected from patients with BCC located at head and neck and who underwent a grafting method. A skin tension lines oriented approach was applied and grafts were harvested from a color matched cosmetic area in these patients.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were selected from the individuals who were admitted or referred to study center (Dr. Hilayda Karakok Private Practice of Dermatology and Venereology).

You may qualify if:

• Patients with nodular basal cell carcinomas with a tumor size equal or less than 12 millimeters
• A history of surgical excision and grafting

You may not qualify if:

• Immunosuppressed patients
• Recurrent tumors
• Patients with BCC's that arose from the previously irradiated area
• Gorlin's Syndrome diagnosis
• Illiterate individuals
• İmpaired cognitive functions

Sponsors & Collaborators

• Sifa Okulu - Independent Research Center of Dermatology and Venereology: lead

Study Sites (1)

Dr. Hilayda Karakök Deri ve Zührevi Hastalıklar Muayenehanesi

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms, Basal Cell; Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma

Study Officials

• Hilayda Karakök Kışla, MD, Specialist of Dermatology

  Dr. Hilayda Karakök Muayenehanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 25, 2025
• Study Start: November 20, 2021
• Primary Completion: February 22, 2025
• Study Completion: February 22, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

TU (1)