Quality of Life Clinical Trial
Official title:
Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes: a Single Academic Institution Study
NCT number | NCT04015453 |
Other study ID # | 825545 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | March 2018 |
Verified date | April 2020 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | March 2018 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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.). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Young VL, Hutchison J. Insights into patient and clinician concerns about scar appearance: semiquantitative structured surveys. Plast Reconstr Surg. 2009 Jul;124(1):256-65. doi: 10.1097/PRS.0b013e3181a80747. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Physician Observer Scar Assessment Scale (POSAS) | Please refer to description above. | 3 month postoperative measure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |