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

NCT05941351 | Not Yet Recruiting

• 1 other identifier: METCZ20230049
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complications requiring an intervention

  The main study parameter is the incidence of complications requiring interventions in both groups. This consists of: * Clinically significant seroma, requiring aspirations in the case of: * Pain or discomfort for the patient caused by large amounts of seroma characterised by tenderness of the skin. * Signs of infection (redness, swelling, pain). * Signs of delayed wound healing (wound breakdown, necrosis, seroma leakage). * Surgical site infections, requiring oral/iv antibiotics or surgical drainage. * Bleeding complications, requiring re-intervention, aspiration or surgical debridement.

  3 months

Secondary Outcomes (2)

• Surgery time

  during surgery

• Cosmetic outcome

  3 months

Study Arms (2)

Running

OTHER

Group 1: Flap fixation after mastectomy with running sutures.

Procedure: flap fixation

Individual

OTHER

Group 2: Flap fixation after mastectomy with interrupted sutures.

Procedure: flap fixation

Interventions

flap fixation PROCEDURE

flap fixation using running or interrupted sutures

Individual; Running

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland MC

Sittard, Limbrug, 6162BG, Netherlands

Location

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Merel Spiekerman van Weezelenburg, MD

CONTACT

+31884597777; m.spiekermanvanweezelenburg@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)