Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasms

Facies

Alopecia

Alopecia Areata

Skin Neoplasms

Skin Diseases

Hypotrichosis

Hair Diseases

Pathological Conditions, Anatomical

Patients undergoing biopsy (incisional or excisional) of peri-ocular lesions. Pre-operative examination for presence or absence of lanugo hairs

Pre-operative examination for presence or absence of lanugo hairs

Examination for presence or absence of lanugo hairs

Robert G Peden, MA; MBBS

Mark R Wright

Hannah Timlin

Skin cancers around the eye are common, but so are other lid lumps. It is useful to be able to tell which lumps are likely to be cancer.

This study looks at whether the loss of fine hairs (lanugo hairs) on the skin are a good indicator of whether a lump is a skin cancer or not.

The investigators are recruiting patients who have lid lumps who haven't had a biopsy before, who would be having a biopsy as part of their treatment, and seeing whether those who have loss of the fine skin hairs are the same as those who have skin cancer confirmed on their biopsy.

The study doesn't involve any extra examinations or treatments for participants. The investigators look at the patients before the biopsy as part of their usual care, and take a note of whether or not they have lost the fine hairs at this stage.

The main benefit of participating is that the medical community has better evidence about which lid lumps are likely to represent skin cancer, helping future diagnosis.

There are no additional risks to participating. The risks of biopsy are unchanged whether patients participate in the study or not.

The study is run from the Princess Alexandra Eye Pavilion in Edinburgh, in conjunction with Moorfields Eye Hospital, London

The investigators aim to start the study in Spring 2018, and will most likely recruit for 6 months depending on the number of participants recruited.

There is no additional funding from any source at present - the work will be undertaken by doctors in their research time.

Lanugo Hair Loss as a Marker for Peri-ocular Malignancy

Examination for the presence or absence of lanugo hairs prior to biopsy

Moorfields Eye Hospital NHS Foundation Trust

Robert Peden

Speciality Registrar

Infections

Wounds and Injuries

Immune System Diseases

Eye Diseases

Communicable Diseases

Surgical Wound Infection

Hypersensitivity

Surgical Wound

Wound Infection

Eyelid Diseases

Disease Attributes

Postoperative Complications

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Pharmaceutical Solutions

Dermatologic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Lubricant Eye Drops

Petrolatum

Mineral Oil

Polymyxins

Bacitracin

Enzyme Inhibitors

Anti-Infective Agents, Local

Intervention: 200 patients in the antibiotic arm will receive either erythromycin or bacitracin, based on allergies, surgeon preference, and antibiotic availability. If neither antibiotic is obtainable by the patient, bacitracin polymyxin will be prescribed instead. Antibiotic ointment is to be applied to the surgical incision(s) 4 times daily for 1 week.

Intervention: 200 patients in the placebo group will receive mineral oil/petrolatum-based artificial tear ointment to be applied to the surgical incision(s) 4 times daily for 1 week.

Topical antibiotic ointment will be erythromycin or bacitracin. If the patient cannot obtain either (e.g. lack of availability at the pharmacy), bacitracin polymyxin will be prescribed. Allergy to all 3 study drugs means that a patient will be excluded from the study.

Topical Antibiotic Product

Mineral oil/petrolatum-based artificial tear ointment.

Topical Non-Antibiotic Ointment

Robert Kersten, MD

The investigators propose a prospective randomized control trial testing the hypothesis that routine topical antibiotic prophylaxis does not significantly reduce the rate of infection after eyelid surgery.

The use of prophylactic topical antibiotic therapy after eyelid surgery is widespread. Due to increasing antibiotic resistance, antibiotic-related complications, and healthcare costs, the investigators wish to determine whether prophylactic post-operative antibiotic ointment is truly necessary. After all, existing dermatology literature currently recommends against the routine use of antibiotic ointment after various surgical procedures (e.g. Mohs surgery). The investigators aim to perform a prospective randomized control trial at the University of California, San Francisco. The investigators aim to recruit a total of 400 oculoplastics patients undergoing eyelid surgery or surgery involving peri-orbital incisions from 2017 through 2019.

Patients will be randomized to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) and will not at any point cross over to the other arm.

Randomization to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) will be performed prior to study recruitment by REDCap software. Patients' randomization assignments will be revealed at the initial pre-operative visit or at time that procedure consent is obtained; the study team will not be aware of a subject's randomization assignment prior to that time.

Topical Antibiotic Prophylaxis for Eyelids

The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery

The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.

A secondary outcome is the rate of superficial or deep SSI in participants considered high risk for infection due to comorbidities such as smoking, exogenous immunosuppressive agent use, or medical conditions causing immunosuppression such as diabetes mellitus.

A secondary outcome recording the rate of wound dehiscence after surgery.

A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.

University of California, San Francisco

Among participants who did not proceed with surgery or who had no post-operative follow-up, adverse event data for events specific to the post-operative period (i.e. allergic contact dermatitis or wound dehiscence) were not collected. These participants were excluded from the denominator in determining frequency of these adverse events.

The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.

Topical Antibiotic Ointment

The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Smoking status

Participants were considered high risk for infection if they had a history of smoking or a medical history of a condition associated with immune suppression, such as diabetes mellitus, infection with human immunodeficiency virus, or autoimmune disease requiring immunosuppressive agents.

High risk for infection

Asplenia

Autoimmune disease

Diabetes mellitus

Human immunodeficiency virus infection

Malignancy

Organ transplantation

Blepharoplasty

Browplasty

Dacryocystorhinostomy

Ectropion/Entropion repair

Eyelid lesion removal and/or biopsy

Ptosis repair

Reconstruction after Mohs surgery

Orbitotomy

Tarsorrhaphy

Wedge excision

Data not available for 3 participants who did not proceed with surgery.

Davin Ashraf MD

Number of Participants With Surgical Site Infections

Number of High Risk Participants With Surgical Site Infections

Number of Participants With Wound Dehiscence

Number of Participants With Allergic Contact Dermatitis

Overall Study

Blood and Lymph Conditions

Hemorrhage

Edema

Postoperative Hemorrhage

Ecchymosis

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Coagulants

Vasoconstrictor Agents

Respiratory System Agents

Lidocaine

Anesthetics

Tranexamic Acid

Epinephrine

Anesthetics, Local

Racepinephrine

Epinephryl borate

Sodium Channel Blockers

Diuretics, Potassium Sparing

Antifibrinolytic Agents

Hemostatics

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

The control arm will receive the current standard of care. Before incision, local anesthetic (1% lidocaine with 1:100,000 epinephrine) will be injected subcutaneously into the surgical site. The surgical team will inject approximately 0.8mL per square centimeter of the surgical site area (defect area and undermined tissue area).

The experimental arm will receive local anesthetic (1% lidocaine with 1:100,000 epinephrine) and TXA (1g/10mL) in a 9:1 volume ratio. This will be injected subcutaneously into the surgical site. The surgical team will inject approximately 0.8mL per square centimeter of the surgical site area (defect area and undermined tissue area).

Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine) and tranexamic acid (1g/10mL), mixed in a 9:1 volume ratio.

Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)

Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine)

Control (1% lidocaine with 1:100,000 epinephrine)

Connie Ma, MD

Priyesh Patel, MD

This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.

Tranexamic acid (TXA) is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA has been extensively described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding and epistaxis. Studies have suggested administration of TXA may improve outcomes in aesthetic surgery as well, specifically regarding intraoperative bleeding and postoperative ecchymosis and hematoma formation. TXA may be administered systemically, via IV or PO routes, or locally, via topical application or subcutaneous injection. Local administration allows for similar benefits with minimal risk of systemic effects.

Following facial Mohs reconstruction patients often experience surgical site ecchymosis and swelling, which may be distressing, painful, prolong healing, and result in increased healthcare utilization. Other complications include hematoma, wound dehiscence, and suboptimal scarring. Given the growing body of literature demonstrating the benefits of TXA in surgical bleeding outcomes, TXA may also be beneficial in improving postoperative Mohs complications and patient satisfaction.

To date, no studies have investigated the use of perioperative TXA specifically in nasal Mohs reconstruction. This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.

In this study, patients undergoing Mohs reconstruction of the nose with local flap techniques will be randomized to receive either standard of care (subcutaneous injection of local anesthetic, 1% lidocaine with 1:100,000 epinephrine) or TXA treatment (subcutaneous injection of local anesthetic, 1% lidocaine with 1:100,000 epinephrine and TXA 1g/10mL, in 9:1 volume ratio) pre-operatively. Outcomes will include intraoperative bleeding and postoperative swelling and bruising.

Patient participants will be blinded to the study arm to which they belong. Additionally, the independent reviewer of postoperative photos will be blinded to the study arm to which patients belong. Participation will end at the 7-day follow up appointment, at which time data collection will cease and treatment group will be disclosed to participants.

Provisions for breaking blinding would include a rare thromboembolic event or anaphylactic event of unknown cause in the immediate postoperative period, or patient desire to terminate involvement in the study.

Tranexamic Acid in Nasal Mohs Reconstruction

Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis

There are no current plans to make IPD available to other researchers. However, if information is made available, to protect patient privacy, patient names will not be released.

Photos will be taken by a research team member at the first postoperative clinic visit and then analyzed and graded by a blinded reviewer for measures including surgical site bruising and swelling. Surgical site swelling and bruising will be graded on a 4 point scale, with 0 indicating no swelling and bruising and 3 indicating significant swelling and bruising.

Subjective measures of patient perceived swelling and bruising will be collected via a patient completed survey given at the first postoperative clinic visit. Surgical site swelling and bruising will be graded on a 4 point scale, with 0 indicating no swelling and bruising and 3 indicating significant swelling and bruising.

Intraoperative bleeding will be assessed using the validated Boezaart Bleeding scale (6 point scale, with 0 indicating no bleeding/cadaveric conditions and 5 indicating severe bleeding/constant suctioning required). Values will be assigned by the attending surgeon and recorded by the research team.

Attending surgeon will score the approximate percent blood saturation of each surgical sponge used in the case. Values from each sponge will be added together for a total cumulative value, with a higher cumulative value indicating a greater amount of intraoperative bleeding.

Subjective measure of patient perceived pain will be collected via a patient completed survey given at the first postoperative clinic visit. Responses will be graded on a 5 point scale, with 1 indicating "no pain" and 5 indicating "severe pain."

Objective measure of pain control will also be collected with an estimate of total amount of opioid pain medication used in the first week after surgery.

Subjective measure of postoperative patient satisfaction will be collected via a patient completed survey given at the first postoperative clinic visit. Responses will be graded on a 5 point scale, with 1 indicating "very dissatisfied" and 5 indicating "very satisfied."

Vanderbilt University Medical Center

Asst. Professor of Otolaryngology

Behaviors and Mental Disorders

Quality of Life

Other Dietary Supplements

Benzocaine

Tannic Acid

Control participants receive treatment for a facial skin cancer with Mohs micrographic surgery (MMS), however, do not receive a peer mentor. Participants complete 3 online Skin Cancer Index (SCI) surveys at enrollment, 1 week follow-up, and 3 month follow-up.

Mentees are enrolled at preoperative consultation visit and paired with a peer mentor throughout their treatment of a facial cancer with MMS. Participants have regular contact with their mentor and complete 3 online SCI surveys at enrollment, 1 week follow-up, and 3 month follow-up.

Mentees are enrolled at same day surgery visit and paired with a peer mentor throughout their treatment of a facial cancer with MMS. Participants have regular contact with their mentor and complete 3 online SCI surveys at enrollment, 1 week follow-up, and 3 month follow-up.

Mentee participants are paired with a previous MMS patient (Mentor) who is greater than 1 year status post MMS treatment for a facial skin cancer. Mentors and mentees maintain regular contact by telephone, video chat, or in-person meetings throughout the mentee's facial skin cancer treatment with MMS.

Peer Mentorship Program

More than 5 million skin cancer surgeries are performed each year in the United States with 80% of tumors appearing on the head and neck. Facial skin cancer diagnosis negatively affects patient quality of life (QOL) and treatment of skin cancer creates visible scars early in the postoperative period, increases anxiety, and impairs social interactions. We believe that these negative psychosocial changes represent an unmet need for additional social support and practical guidance. A one-to-one peer support program designed for skin cancer patients could provide a focused, cost-effective, patient-centered intervention to improve quality of life and increase satisfaction. Comparable one-to-one peer support programs have demonstrated high rates of patient satisfaction and positive QOL outcomes in a wide range of conditions. This prospective peer support program would be the first of its kind for melanoma and keratinocytic skin cancers. Our pilot program was designed in consultation with leading peer mentorship program researchers and we will implement a structured system to match volunteer mentors with patients. Through qualitative and quantitative data, we will evaluate the program's effect on patient QOL at 3 separate intervals: at initial consultation, 1-2 weeks post-surgery, and 3 months post-surgery. We hope that this study will enable us to design and execute a larger multi-center clinical trial in order to establish a best practice for surgeons to usher patients through the postoperative healing process after skin cancer surgery.

Skin cancer is a common, often chronic condition that negatively impacts patient quality of life. Currently, more than 5 million skin cancer surgeries are performed in the United States each year, at a cost of over $8 billion per year. Eighty percent of these tumors occur on the head and neck, anatomic sites most visible to society. Recent studies have demonstrated that patients have reduced concern about the severity and prognosis of their skin cancer in the period immediately following Mohs micrographic surgery (MMS). However, patient QOL related to appearance and social interactions is impaired in the weeks following MMS due to elevated distress regarding post-surgical physical appearance.

One-to-one peer support programs benefit both the patient and the mentor. In one-to-one peer support programs, individuals previously affected by a disease or condition volunteer to provide support to current patients in a loosely structured, mentorship setting. Peer mentors provide mentees with social and emotional support as well as practical guidance on health system navigation. Similar peer mentorship programs with burn patients who had significant changes to outward physical appearance resulted in positive experiences for both mentee and mentor. Notable mentee feedback included the formation of an immediate connection with a peer supporter and feelings of "automatic trust" even after previously seeing a mental health professional for their care. Mentors described their participation in peer programs as a source for continued learning and inspiration for their own recovery.

One-to-one peer support is a cost-effective, well-received intervention that increases patient satisfaction and objective QOL measures across many fields. Outcome measurements of one-to-one peer mentorship programs have demonstrated high rates of patient satisfaction and positive psychological outcomes in patients suffering from diabetes, breast cancer, prostate cancer, colon cancer, and gynecologic cancers. The operating cost of peer support mentorship is low, and these programs can further relieve the health care system by reallocating access to patient support services to a community level.

Buddy Relationships in DermatoloGic Excisions for Skin Cancer

Buddy Relationships in DermatoloGic Excisions for Skin Cancer ("BRIDGES"): A Trial of One-to-one Peer Support in Patients With Facial Skin Cancers Treated With Mohs Surgery

Primary study measures include patient responses from the Skin Cancer Index (SCI), a disease-specific, 15-question validated QOL instrument. The SCI is divided into 3 subscales: appearance, emotion, and social domains. Higher scores indicate increased QOL.

Secondary measures will include a post study exit survey to evaluate participant satisfaction and program feedback via qualitative and quantitative variables.

Abramson Cancer Center at Penn Medicine

Cicatrix

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.

patient's psychological experience the anxiety level

Self-administered questionnaires by the patient will be given during visits in the following order:the self-administered questionnaires concerning the announcement consultation will be completed by the patient after consultation waiting room; self-questionnaires will be given in just before the operation waiting room (D0) just before the suture removal points (J10) and just before the follow-up visit (M3).

Self-administered questionnaires

Marie BEYLOT-BARRY, MD, PhD

Surgery is the first-line treatment of localized skin cancers. Knowledge on the patient's psychological experience is limited. Therefore, the psychological impact on patients before, during and after surgery can be underestimated. Moreover, the diagnosis of cancer disturbs the patient's entire life and the onset of anxiety disorders is frequent following this announcement.

The main objective of the study is to explore patients' experience assessing anxiety before, during and away from surgery. The investigators will distinguish the anxiety related to the surgical act itself and the anxiety related to the announcement of the disease.

The secondary objective is to assess the impact of surgery on quality of life, self-image and aesthetic satisfaction.

Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department

Self-assessment questionnaires will be given to the patient

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lanugo Hair Loss as a Marker for Peri-ocular Malignancy	NCT03382704	Skin Cancer Fac...	Examination for...	18 Years -	NHS Lothian
Topical Antibiotic Prophylaxis for Eyelids	NCT03199911	Antibiotic Side... Eyelid; Wound Eyelid Diseases Surgical Wound ... Surgical Wound,... Surgical Incisi... Skin Cancer Fac... Antibiotic Alle... Surgical Site I...	Topical Antibio... Topical Non-Ant...	18 Years -	University of California, San Francisco
Tranexamic Acid in Nasal Mohs Reconstruction	NCT06057675	Postoperative B... Skin Cancer Fac...	Treatment (tran... Control (1% lid...	18 Years -	Vanderbilt University Medical Center
Buddy Relationships in DermatoloGic Excisions for Skin Cancer	NCT04036344	Skin Cancer Fac... Quality of Life Surgical Wound Peer Mentorship	Peer Mentorship...	18 Years -	Abramson Cancer Center at Penn Medicine
Lanugo Hair Loss as a Marker for Peri-ocular Malignancy	NCT03382704	Skin Cancer Fac...	Examination for...	18 Years -	NHS Lothian
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
Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department	NCT04336371	Skin Cancer Fac... Surgical Incisi...	Self-administer...	18 Years -	University Hospital, Bordeaux
Tranexamic Acid in Nasal Mohs Reconstruction	NCT06057675	Postoperative B... Skin Cancer Fac...	Treatment (tran... Control (1% lid...	18 Years -	Vanderbilt University Medical Center
Buddy Relationships in DermatoloGic Excisions for Skin Cancer	NCT04036344	Skin Cancer Fac... Quality of Life Surgical Wound Peer Mentorship	Peer Mentorship...	18 Years -	Abramson Cancer Center at Penn Medicine
Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department	NCT04336371	Skin Cancer Fac... Surgical Incisi...	Self-administer...	18 Years -	University Hospital, Bordeaux

Spots Global Cancer Trial Database for skin cancer face