Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Uterine Cervical Neoplasms

Virus Diseases

Papilloma

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Will perform HPV testing with self-collected specimen

will perform HPV testing with self-collected specimen

HPV testing

Transgender men are individuals born genetically female that have a gender identity that is incongruent with their biological sex. For those who have begun or completed transition, they may present as males but still have a uterus and cervix. Thus far, no distinction has been made between routine cervical cancer screening guidelines in non-transgender women and those for transgender men, despite wide variations in sexual practices, including lifelong vaginal abstinence. The purpose of this study is to offer transgender men seen at clinic visits self-collected HPV testing to evaluate for improved cervical cancer screening rates, as well as a survey to further investigate sexual practices, rates of appropriate screening prior to being offered self-collection, and barriers to obtaining appropriate care.

Must be transgender masculine identifying with uterus and cervix.

Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men

Evaluate whether implementation of HPV DNA self swabs will increase rates of cervical cancer screening among transgender men by percentage of trans men who obtain screening through the study

Determine which barriers contribute most to lack of cervical cancer screening among transgender men. Measured via survey.

Evaluate for the presence of high risk behaviors to determine whether transgender men in our population are at higher or lower risk for HPV-related cervical dysplasia. Measured via survey.

Evaluate percentage of transgender men that have been vaccinated for HPV. Measured via survey.

The Equality Clinic of Augusta

Augusta University

Skin and Connective Tissue Diseases

Breast Neoplasms

Gynecomastia

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

This group of patients will have their periareolar incisions closed with 4-0 Prolene sutures which are non-absorbable (require removal) and require knot-tying.

This group of patients will have their periareolar incisions closed with 4-0 Monocryl sutures which are absorbable (do not require removal) and require knot-tying.

This group of patients will have their periareolar incisions closed with 4-0 Stratafix sutures which are absorbable (do not require removal) and do not require knot-tying.

Any surgery involving incisions made along the nipple areolar complex. These would include transgender mastectomy, cisgender female breast reduction/augmentation/reconstruction, and cisgender male gynecomastia correction.

Breast surgery

The closing of a surgical incision by using sutures so appose and maintain apposition of two skin edges. Suturing may or may not require knot-tying depending on the material of suture used.

Suturing of surgical incision

Tanya Delyzer, MD

Aaron Grant, MD

This will be a single-blinded study where participants are blinded to the suture type but the surgeon will draw a random, unmarked envelope containing the designated suture type at the start of the surgery. The patient population will be all patients undergoing breast surgery at the London Health Sciences Center (LHSC) - ie. University Hospital, Victoria Hospital and the Nazem Kadri Surgical Center, and St. Joseph's Hospital. Three (3) main procedure groups will be transgender gender-affirming top surgery, cisgender female breast reduction or augmentation (including healthy and cancer patients; subgroup analysis will be performed), and cisgender male gynecomastia surgery. The goal is n=180 patients, n=60 per type of suture with n=20 per type of procedure (totaling n=60 per type of procedure).

NAC width for each breast will be measured intraoperatively, at 2 weeks postop, 6 weeks postop, 3 months postop, and 6 months postop. These measurements will be deidentified and logged into a secure data entry form. Information on whether a secondary outcome occurred (ie. infection, dehiscence, revision and nipple necrosis) will be logged in this form as well.

Because the sutures will be kept non-visible under dressings until the clinical followup appointment 2 weeks postop, the patient will remain blinded as to the type of suture used on their NAC(s). At this point, absorbable sutures will have been largely dissolved and non-absorbable sutures will be removed.

This will be a single-blinded study where the participants will be blinded to the type of suture. The patient population will be all patients undergoing breast surgery at the London Health Sciences Center (LHSC) - ie. University Hospital, Victoria Hospital and the Nazem Kadri Surgical Center - and St. Joseph's Hospital falling into one of 3 categories: transmasculine gender affirming top surgery, cisgender female elective or oncologic breast surgery (mastopexy, breast reduction, breast augmentation, or nipple-sparing mastectomy), and cisgender male gynecomastia correction.

Three sutures will be used: 4-0 Prolene, 4-0 Monocryl and 4-0 Stratafix. We will aim for n=180 participants, n=60 per type of suture, and n=60 per surgical category. This way, each suture type can be equally distributed among each surgical category. This means n=20 of each suture type will be used in n=20 of each surgery type. For example, n=20 top surgery patients will receive Prolene sutures, n=20 receive Monocryl, and n=20 receive Stratafix. All patients will be consented in the preop area on the day of their surgery by a member of the research team.

The primary outcomes will be NAC diameter or "width" intraoperatively immediately after closing compared to NAC width 2 weeks, 6 weeks, 3 months, and 6 months postoperatively. The horizontal and vertical widths will be measured at each time. Measurements are done with a ruler and recorded in centimeters. Prolene sutures will be removed at the 6-week postop visit as per current clinical practice. Absorbable will not be removed because they are absorbable.

Statistical regression will be used to determine whether a certain type(s) of suture is optimal for minimizing NAC widening after surgery. Subgroup analyses will also be conducted to determine any confounding factors from heterogeneity in patient factors within each group. Secondary outcomes will be rates of infection, tip loss, nipple necrosis and dehiscence, and whether certain types of sutures increase these adverse outcomes.

All patients will receive the surgical treatment they consented for, the only difference among them being the type of suture material used to close their perioareolar incisions (3 different types are investigated in this study).

The type of suture used to close the periareolar incision will be determined by drawing the name of the suture from a random, sealed envelope at the start of the procedure in the operating room. The patient will not be informed of the suture type and they are unable to see the suture type due to postoperative dressings being placed overtop, until they see the surgeon at their 2-week followup appointment.

Effect of Suture Material on Postoperative Nipple Areolar Complex Widening

Effect of Suture Material on Postoperative Nipple Areolar Complex Widening: A Randomized Controlled Trial

Postoperative change in diameter of the nipple areolar complex as an adverse outcome

Death of nipple tissue as an adverse outcome following surgery

Loss of projection of the nipple tip due to effacement as an adverse outcome following surgery

Colonization of the surgical area by bacteria leading to immune response

Separation of the apposed skin edges along the surgical incision

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men	NCT04154358	Transgenderism Cervical Cancer Human Papilloma...	HPV testing	21 Years -	Augusta University
Effect of Suture Material on Postoperative Nipple Areolar Complex Widening	NCT06070324	Breast Cancer Gynecomastia Transgenderism Breast Asymmetr...	Breast surgery Suturing of sur...	18 Years -	Lawson Health Research Institute
Implementing HPV DNA Self-Collection to Increase Rates of Cervical Cancer Screening in Transgender Men	NCT04154358	Transgenderism Cervical Cancer Human Papilloma...	HPV testing	21 Years -	Augusta University

Spots Global Cancer Trial Database for transgenderism