Effect of Suture Material on Postoperative Nipple Areolar Complex Widening

NCT06070324 | Unknown DMC FDA Device

• 1 other identifier: 123476
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer; Gynecomastia; Transgenderism; Breast Asymmetry

Outcome Measures

Primary Outcomes (1)

• Change in nipple areolar complex diameter

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

  1 year

Secondary Outcomes (4)

• Percentage of partial and nipple necrosis

  1 year

• Number of participants experiencing nipple tip loss

  1 year

• Number of participants who contract a postoperative infection

  1 month

• Number of nipples that underwent incision dehiscence

  6 months

Study Arms (3)

Prolene

ACTIVE COMPARATOR

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.

Procedure: Breast surgery; Device: Suturing of surgical incision

Monocryl

ACTIVE COMPARATOR

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.

Procedure: Breast surgery; Device: Suturing of surgical incision

Stratafix

ACTIVE COMPARATOR

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.

Procedure: Breast surgery; Device: Suturing of surgical incision

Interventions

Breast surgery PROCEDURE

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.

Monocryl; Prolene; Stratafix

Suturing of surgical incision DEVICE

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.

Monocryl; Prolene; Stratafix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Breast Neoplasms; Gynecomastia; Transsexualism; Anisomastia

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Tanya Delyzer, MD

CONTACT

519-685-8108; Tanya.delyzer@lhsc.on.ca

Aaron Grant, MD

CONTACT

519-663-3321; aaron.grant@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 6, 2023
• Study Start: December 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share