Effect of Suture Material on Postoperative Nipple Areolar Complex Widening (NCT06070324) | Clinical Trial Compass
UnknownNot Applicable
Effect of Suture Material on Postoperative Nipple Areolar Complex Widening
180 participantsStarted 2023-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any individual undergoing breast surgery of any kind using a periareolar approach including breast reconstruction, mastopexy, mammoplasty gender affirming surgery, mastectomy, or gynecomastia surgery
* Patients undergoing breast surgery at the London Health Sciences Center (LHSC) or St Joseph's Hospital (SJH)
* Participants over the age of 18
* Any BMI
* Any gender
* Patients who are willing to participate in the study and provide informed consent.
Exclusion Criteria:
* Patient does not or cannot consent for enrollment in this study (includes inability to understand the provided information due to illiteracy or unproficiency in English)
* Patient is under the age of 18
* Patients with a known allergy to any type of suture material used in the study.
* For cancer patients who received radiotherapy, the irradiated breast will not be included in the study (the non-irradiated breast remains eligible)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in nipple areolar complex diameter
Timeframe: 1 year
Trial details
NCT IDNCT06070324
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's