- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015453
Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes
April 27, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania
Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes: a Single Academic Institution Study
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
113
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult participants with a biopsy-proven facial skin cancer treated with MMS from 8/2015 to 2/2016.
Description
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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician Observer Scar Assessment Scale (POSAS)
Time Frame: 1 week postoperative measure
|
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)
Time Frame: 3 month postoperative measure
|
Please refer to description above.
|
3 month postoperative measure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2016
Primary Completion (ACTUAL)
November 1, 2016
Study Completion (ACTUAL)
March 1, 2018
Study Registration Dates
First Submitted
July 9, 2019
First Submitted That Met QC Criteria
July 9, 2019
First Posted (ACTUAL)
July 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 28, 2020
Last Update Submitted That Met QC Criteria
April 27, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 825545
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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