Clinical trial · Interventional
Effect of Suture Material on Postoperative Nipple Areolar Complex Widening
Effect of Suture Material on Postoperative Nipple Areolar Complex Widening: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Asymmetry | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecomastia | — | UNRESOLVED | — |
| Transgenderism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast surgery | Procedure | — | UNRESOLVED |
| Suturing of surgical incision | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Prolene
- description
- 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.
- interventionNames
- Procedure: Breast surgery
- Device: Suturing of surgical incision
- type
- ACTIVE_COMPARATOR
- label
- Monocryl
- description
- 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.
- interventionNames
- Procedure: Breast surgery
- Device: Suturing of surgical incision
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available