fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma

NCT ID: NCT05941351

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-03-01

Brief Summary

Rationale: Flap fixation significantly reduces the incidence of seroma formation after mastectomy. Therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle. Previous studies have compared running sutures, interrupted sutures and tissue glue application to conventional wound closure. A recent systematic review with network meta-analysis indicated running sutures as the most optimal technique, however direct comparisons and high quality articles were lacking.

Objective: This prospective trial aims to directly compare running sutures with interrupted sutures in order to prevent complications in patients undergoing a mastectomy.

Study design: This trial will combine a retrospective cohort from the previous SARA-trial in Zuyderland MC with a randomised prospective trial. This study design was chosen to acquire a sample size with sufficient power and the ability to conduct this study in an acceptable time frame.

Study population: A retrospective cohort of patients participating in the SARA trial (RCT) and a prospective cohort of patients undergoing a mastectomy for breast cancer.

Intervention: Group 1: Flap fixation after mastectomy with running sutures. Group 2: Flap fixation after mastectomy with interrupted sutures.

Main study parameters/endpoints: The primary endpoint is the incidence of complications requiring interventions in both groups, including clinically significant seroma, infections and bleeding complications. Secondarily, the length of the procedure and cosmetic results will be compared.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: When participating, patients will undergo 3 additional outpatient clinic visits. Study visits will be combined with regular visits where possible, including the first postoperative visit after 7-10 days and either the 6 week or 3 month visit.

Conditions

Seroma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Running

Group 1: Flap fixation after mastectomy with running sutures.

Group Type: OTHER

flap fixation

Intervention Type: PROCEDURE

flap fixation using running or interrupted sutures

Individual

Group 2: Flap fixation after mastectomy with interrupted sutures.

Group Type: OTHER

flap fixation

Intervention Type: PROCEDURE

flap fixation using running or interrupted sutures

Interventions

flap fixation

flap fixation using running or interrupted sutures

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female sex.
• 18 years or older.
• Indication for mastectomy.

Exclusion Criteria

• Patients undergoing breast conserving therapy
• Patients undergoing direct breast reconstruction
• Patients undergoing modified radical mastectomy
• Unable to comprehend implications and extent of study and sign for informed consent

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zuyderland MC

Sittard, Limbrug, Netherlands

Countries

Netherlands

Central Contacts

Merel Spiekerman van Weezelenburg, MD

Role: CONTACT

m.spiekermanvanweezelenburg@zuyderland.nl

+31884597777

Facility Contacts

Merel Spiekerman van Weezelenburg, MD

Role: primary

m.spiekermanvanweezelenburg@zuyderland.nl

+31884597777

Other Identifiers

METCZ20230049

Identifier Type: -

Identifier Source: org_study_id