Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Behaviors and Mental Disorders

Skin Neoplasms

Cicatrix

Facies

Surgical Wound

Quality of Life

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

Mohs micrographic surgery

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.

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.

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

Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes: a Single Academic Institution Study

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.

Abramson Cancer Center at Penn Medicine

Carcinoma

Neoplasm Metastasis

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Oxytetracycline

Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch.

Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing

A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.

MMS + Autologous patch

Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)

MMS and secondary intention healing

Katrine E Karmisholt, MD, PhD

Anna A Harager, Bsc

Katrine E Karmisholt, Ph.D.

Anna A Harager

The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.

Blinded photo assesment of wound healing by two independent trained clinical doctors.

Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery

Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial

Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.

Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no.

Trans epidermal water loss (TEWL) will be meassured at day 11-13 and day 18-20. The TEWL will be meassured on the wound healing site and the contralateral site of the patient's face as a control.

The POSAS observer scores scar components with regards to: Vascularity, pigmentation, thickness, surface area, relief and pliability. The collected sum of scores will range from minimum 6 points to maximum 60 points.

Swab test for microbiome analysis will be conducted at day 1 and day 11-13.

Benzon Foundation

Bispebjerg Hospital

MD, Chief Consultant, Ass.Prof., PhD

Rare Diseases

Carcinoma, Squamous Cell

Recurrence

Melanoma

Lentigo

Hutchinson's Melanotic Freckle

Postoperative Complications

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Disease Attributes

Melanosis

Hyperpigmentation

Pigmentation Disorders

Lentigo Maligna Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Formaldehyde

Patients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Patients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).

Mohs surgery

Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).

Slow Mohs surgery

Emmy Cruts, MD

E Cruts, MD

K Mosterd, MD, PhD

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Clinical Presentation and Surgical Outcomes in Patients With Skin Disorders Treated With Mohs Micrographic Surgery and Slow Mohs.

The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages.

The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages. Recurrence is defined as disease relapse after completion of treatment.

Predisposing factors (patient- and tumor characteristics) for complications after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize the presence of diabetes, tobacco use and medication use to be predisposing factors for complications.

Predisposing factors (patient- and tumor characteristics) for recurrences after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize incomplete treatment, worse prognostic tumor factors (Stage III of IV, presence of perineural invasion or lymphovascular invasion) to be predisposing factors for recurrence.

Maastricht University Medical Center

Dermatofibrosarcoma

Fibrosarcoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Dermatofibrosarcoma Protuberans

Soft Tissue Sarcoma

Patients who have their dermatofibrosarcoma protuberans excised with MOHS surgery.

Mohs surgery is a precise surgical technique used to treat skin cancer. Thin layers of cancer-containing skin are progressively removed and examined microscopically until only cancer-free tissue remains.

MOHS micrographic surgery

A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.

Wide local excision

Randall K Roenigk

The purpose of this proposed study is to assess effectiveness of MOHS micrographic surgery as a form of treatment for dermatofibrosarcoma protuberans in patients who are 10 years of age or younger through review of the patients at Mayo Clinic treated from 1988-2017, and to explore the challenges that providers face which may prevent them performing this potentially superior treatment. This study will provide a comparison of outcomes and recurrence rates in pediatric patients treated by MOHS versus traditional excision.

Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

Developing an additional dermatofibrosarcoma protuberans at any location, but particularly noting local recurrence (defined as being within or contiguous to the field of the previous excision.

Death which is directly related to the dermatofibrosarcoma or complications related to it as judged by clinical investigators

Will be measured by the area of tissue removed and any functional or physical impairment which resulted from the surgical procedure such as limited range of motion, resulting reported pain, or any reported complications.

Mayo Clinic

Professor of Dermatology

Patients from the existing Optum insurance claimed database with a confirmed diagnosis of melanoma, basal cell carcinoma, or squamous cell carcinoma who have undergone skin cancer excision surgery followed by interpolated flap repair between the years 2001-2006.

Jeremy Etzkorn, MD

Mohs micrographic surgery (MMS) followed by skin reconstruction has been widely accepted for treatment of many skin cancers. To further characterize the trends in MMS and reconstruction for skin cancer, a retrospective analysis will be performed using the Optum© Clinformatics® DataMart de-identified commercial claims database from 2001-2016. The findings may provide critical data for future prospective studies in skin cancer treatments.

Mohs Micrographic Surgery and Reconstruction in the Optum Insurance Claims Database

Characterizing Trends in Mohs Micrographic Surgery and Complex Reconstruction in the Optum Healthcare Population

How does interpolation flap procedure cost differ across settings

How does medical specialty or geographical location predict where the procedure is performed

University of Pennsylvania

Melanoma, Cutaneous Malignant

The primary purpose of this study is to address the limited knowledge regarding patient well- being and nasal function after interpolated flap repair of post-Mohs surgical defects on the nose. Improved understanding of the patient experience will allow providers to better counsel their patients pre-operatively and potentially identify patients who may benefit from additional interventions.

This project is a multi-center prospective cohort study evaluating postoperative complication rates, quality of life outcomes, and nasal function after interpolated flap repair of post-Mohs surgical defects of the nose. Our primary outcome is the incidence of short-term complications(within 4 weeks of surgery) defined by the American College of Mohs Surgery as: death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative complication, and surgical site infection. Secondary outcomes will include incidence of flap necrosis and evaluation of quality of life at 1, 4 and 16 weeks after repair. Quality of life will be investigated using the Skin Cancer Index (SCI)- a skin cancer specific quality of life instrument and the Nasal Appearance and Functional Evaluation Questionnaire (NAFEQ). Previous literature has demonstrated that Mohs surgery in the outpatient setting has a very low complication rate but this literature is generally limited to single-institution studies or studies examining smaller repairs. Furthermore, it has been proven that receiving a skin cancer diagnosis is stressful and patient satisfaction with skin cancer surgery is related to their appearance and scarring or changes in appearance can decrease quality of life. Our study serves to fill the current literature knowledge gaps by examining repair of large defects and looking at both complications and quality of life outcomes. Data collection will begin pre-operatively on patients 18 and older who require an interpolated flap repair of a post-Mohs surgical defect. These patients will then be followed and asked to complete SCI and NAFEQ surveys as well as complication questionnaires at prescribed intervals. All data will be stored via a secure RedCap database.

Interpolated Flap Study

Postoperative Complications, Nasal Function, and Quality of Life Following Interpolated Flap Repair for Post-Mohs Surgical Defects of the Nose: a Multi-center Prospective Observational Cohort Study

Short term (30 day) complications are defined by the American College of Mohs Surgery as death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative outcome, and surgical site infection.

Skin Cancer Index is 15-item, disease specific, validated, quality of life instrument with three sub-scales, Emotion, Social, Appearance. A 5-point response format is used for each question where 1 equals "very much" and 5 equals "not at all". Standardized Scores Range from 0-100 with higher scores indicating higher quality of life. Standardized scores are obtained by summing the individual scores and dividing them by the number of items in each sub-scale.

The NAFEQ is a 14-item, validated quality of life instrument with two sections. The first seven items regard nasal function and airway passage, while the following seven questions assess satisfaction with nasal appearance. Responses are rated on a 5-point Likert scale where 1 equals "always" or "very dissatisfied", depending on the question, and 5 equals "never" or "very satisfied". Potential scores range from 7-35 with higher scores indicating greater satisfaction with overall nasal functioning and appearance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes	NCT04015453	Scar Surgical Wound Quality of Life Mohs Micrograph... Skin Cancer Fac...	Mohs micrograph...	18 Years -	Abramson Cancer Center at Penn Medicine
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery	NCT05170035	Skin Cancer Basal Cell Carc...	MMS + Autologou... MMS and seconda...	18 Years - 100 Years	Bispebjerg Hospital
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery	NCT05170035	Skin Cancer Basal Cell Carc...	MMS + Autologou... MMS and seconda...	18 Years - 100 Years	Bispebjerg Hospital
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs	NCT06014619	Skin Cancer Complication Complication of... Complication,Po... Recurrence Recurrent Disea... Cutaneous Squam... Basal Cell Carc... Lentigo Maligna Lentigo Maligna...	Mohs surgery Slow Mohs surge...	16 Years -	Maastricht University Medical Center
Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger	NCT03381846	Dermatofibrosar...	MOHS micrograph... Wide local exci...	1 Year - 10 Years	Mayo Clinic
Mohs Micrographic Surgery and Reconstruction in the Optum Insurance Claims Database	NCT04117373	Skin Cancer Mohs Micrograph... Interpolated Fl...		1 Year - 99 Years	University of Pennsylvania
Interpolated Flap Study	NCT04164550	Skin Cancer, No... Skin Cancer Mel... Mohs Micrograph...		18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for mohs micrographic surgery