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

Seroma Clinical Trial

— ANNIE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941351
• Other study ID #: METCZ20230049
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: March 1, 2027

Study information

• Verified date: June 2023
• Source: Zuyderland Medisch Centrum
• Contact: Merel Spiekerman van Weezelenburg, MD
• Phone: +31884597777
• Email: m.spiekermanvanweezelenburg[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 361
• Est. completion date: March 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Seroma

Intervention

Procedure:
• flap fixation
flap fixation using running or interrupted sutures

Locations

Country	Name	City	State
Netherlands	Zuyderland MC	Sittard	Limbrug

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgery time	surgery time in minutes	during surgery
Secondary	Cosmetic outcome	• Cosmetic results measured using a numeric rating score (NRS) from 0-10, in which 0 equals very dissatisfied with the cosmetic results and 10 equals very satisfied with the results.	3 months