The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05941351
Recruitment Status : Not yet recruiting
First Posted : July 12, 2023
Last Update Posted : July 12, 2023
Sponsor:
Information provided by (Responsible Party):
Zuyderland Medisch Centrum

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Seroma Procedure: flap fixation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma
Estimated Study Start Date : January 1, 2025
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Running
Group 1: Flap fixation after mastectomy with running sutures.
 Procedure: flap fixation
flap fixation using running or interrupted sutures
Individual
Group 2: Flap fixation after mastectomy with interrupted sutures.
 Procedure: flap fixation
flap fixation using running or interrupted sutures


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Complications requiring an intervention [ Time Frame: 3 months ]

    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.


Secondary Outcome Measures :
  1. Surgery time [ Time Frame: during surgery ]
    surgery time in minutes

  2. Cosmetic outcome [ Time Frame: 3 months ]
    • 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05941351


Contacts
Layout table for location contacts
Contact: Merel Spiekerman van Weezelenburg, MD +31884597777 m.spiekermanvanweezelenburg@zuyderland.nl

Locations
Layout table for location information
Netherlands
Zuyderland MC
Sittard, Limbrug, Netherlands, 6162BG
Contact: Merel Spiekerman van Weezelenburg, MD    +31884597777    m.spiekermanvanweezelenburg@zuyderland.nl   
Sponsors and Collaborators
Zuyderland Medisch Centrum
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT05941351    
Other Study ID Numbers: METCZ20230049
First Posted: July 12, 2023    Key Record Dates
Last Update Posted: July 12, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Seroma
Inflammation
Pathologic Processes