Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes

NCT04015453 | Completed

• 1 other identifier: 825545
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scar; Surgical Wound; Quality of Life; Mohs Micrographic Surgery; Skin Cancer Face

Outcome Measures

Primary Outcomes (2)

• Physician Observer Scar Assessment Scale (POSAS)

  The Patient and Observer Scar Assessment Scale (POSAS) is a validated scoring instrument that takes into account patient, physician, and third-party observer input to evaluate postsurgical scar quality in clinical photos. The instrument has 6 patient and 6 observer specific questions. Scoring of each question is performed on a scale of 1 to 10 where 1 is synonymous with "like normal skin" and 10 to the "worst scar imaginable". In addition, an overall total opinion score on a scale from 1 to 10 where 1 is akin to normal skin and 10 to the worst scar imaginable. Consequently, higher scores on either scale represent a worse scar appearance in the perception of the rater.

  1 week postoperative measure

• Physician Observer Scar Assessment Scale (POSAS)

  Please refer to description above.

  3 month postoperative measure

Interventions

Mohs micrographic surgery PROCEDURE

All participants will have received Mohs micrographic surgical treatment for a facial skin cancer.

Eligibility Criteria

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

Study Population

Adult participants with a biopsy-proven facial skin cancer treated with MMS from 8/2015 to 2/2016.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Related Publications (7)

• 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.

  PMID: 18617450 BACKGROUND

• 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.

  PMID: 19568089 BACKGROUND

• 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.

  PMID: 25474194 BACKGROUND

• 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.

  PMID: 15253184 BACKGROUND

• 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.

  PMID: 29381545 BACKGROUND

• 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.

  PMID: 27317520 BACKGROUND

• 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.

  PMID: 29392275 BACKGROUND

MeSH Terms

Conditions

Cicatrix; Surgical Wound

Interventions

Mohs Surgery

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Microsurgery; Surgical Procedures, Operative; Dermatologic Surgical Procedures; Plastic Surgery Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 11, 2019
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2018
• Last Updated: April 28, 2020

Record last verified: 2020-04