An interventional study of flap fixation in Seroma, sponsored by Zuyderland Medisch Centrum. Not yet recruiting at 1 site in Netherlands. Open to female participants. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Prevention
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's planned enrollment of 361 is above the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1: Flap fixation after mastectomy with running sutures.
Procedure: flap fixation
Group 2: Flap fixation after mastectomy with interrupted sutures.
Procedure: flap fixation
flap fixation using running or interrupted sutures
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.
Time frame: 3 months
Surgery time
surgery time in minutes
Time frame: during surgery
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.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Jan 2027, 24 months later.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's planned 24 months is below that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Zuyderland Medisch Centrum