Clinical trial NCT04015453: Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes
Official title: Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes: a Single Academic Institution Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scar
Surgical Wound
Quality of Life
Mohs Micrographic Surgery
Skin Cancer Face
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with a biopsy-proven facial skin cancer treated with MMS from 8/2015 to 2/2016.

Brief summary: A retrospective cohort study of early and late period postoperative scars using previously validated survey measures and clinical photographs. The target population consists of participants treated with Mohs micrographic surgery (MMS) for a facial skin cancer by the division of dermatologic surgery. This study aims to determine if patient assessment of scar appearance correlates with physician ratings and/or third-person observer ratings. Secondary goals are to assess for correlations between early post-operative scar appearance and long-term scar appearance as well as identification of predictive factors for scar healing.

Detailed description: Scarring is an inevitable outcome of surgical manipulation of the skin. Previous studies have shown that postoperative scarring, especially in cosmetically sensitive areas, may negatively affect patient quality of life and social interactions. The impact of surgical scarring is magnified in Mohs micrographic surgery, for which the large proportion of treated lesions are in highly visible areas, such as the head, face, and neck. Clinicians often underestimate the significance of scarring in patients' daily activities. Patients desire quick healing surgical scars in order to reintegrate into their normal social routines. Anecdotal evidence suggests that scars that heal well early in the post-operative period will achieve better results in the late postoperative period. Determining a model of early and late surgical scar evolution, as rated by patients, physicians, and third-party observers may; 1. Identify gaps between physician and patient evaluations; 2. Assist clinicians in effectively evaluating and counseling patients regarding their post-operative scar appearance.

Eligibility criteria: Inclusion Criteria:

* Adult participants diagnosed with a biopsy-proven facial skin cancer (melanoma and non-melanoma skin cancers) and treated with Mohs micrographic surgery (MMS) from August 2015 to February 2016.

Exclusion Criteria:

* Participants with post-excisional reconstruction requiring multiple techniques, incomplete or missing patient photographs from postsurgical visits, or if the patient received any postoperative scar interventions (pulse-dye laser, scar revision, etc.).

Primary outcomes:
measure: Physician Observer Scar Assessment Scale (POSAS)
timeFrame: 1 week postoperative measure
measure: Physician Observer Scar Assessment Scale (POSAS)
timeFrame: 3 month postoperative measure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Brown BC, McKenna SP, Siddhi K, McGrouther DA, Bayat A. The hidden cost of skin scars: quality of life after skin scarring. J Plast Reconstr Aesthet Surg. 2008 Sep;61(9):1049-58. doi: 10.1016/j.bjps.2008.03.020. Epub 2008 Jul 9.
citation: Young VL, Hutchison J. Insights into patient and clinician concerns about scar appearance: semiquantitative structured surveys. Plast Reconstr Surg. 2009 Jul;124(1):256-265. doi: 10.1097/PRS.0b013e3181a80747.
citation: Dey JK, Ishii LE, Byrne PJ, Boahene KD, Ishii M. The social penalty of facial lesions: new evidence supporting high-quality reconstruction. JAMA Facial Plast Surg. 2015 Mar-Apr;17(2):90-6. doi: 10.1001/jamafacial.2014.1131.
citation: Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
citation: Shao K, Parker JC, Taylor L, Mitra N, Sobanko JF. Reliability of the Patient and Observer Scar Assessment Scale When Used With Postsurgical Scar Photographs. Dermatol Surg. 2018 Dec;44(12):1650-1652. doi: 10.1097/DSS.0000000000001479. No abstract available.
citation: Sobanko JF, Zhang J, Margolis DJ, Etzkorn JR, Shin TM, Sarwer DB, Miller CJ. Patient-reported quality of life and psychosocial health prior to skin cancer treatment - A cross-sectional study. J Am Acad Dermatol. 2016 Jul;75(1):217-218.e2. doi: 10.1016/j.jaad.2016.01.033. No abstract available.
citation: Zhang J, Miller CJ, O'Malley V, Bowman EB, Etzkorn JR, Shin TM, Sobanko JF. Patient and Physician Assessment of Surgical Scars: A Systematic Review. JAMA Facial Plast Surg. 2018 Jul 1;20(4):314-323. doi: 10.1001/jamafacial.2017.2314.