Uz Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location contact
Felix De Bruyn, Medical doctor
CONTACT
Felix De Bruyn, Medical doctor
PRINCIPAL_INVESTIGATOR
Julie Paternoster, Medical doctor
CONTACT
NCT Number: NCT06468488
Inserting surgical drains is an ancient approach used across different specialties because of its many advantages such as discharge of fluid accumulation, appraising and qualifying drain capacities, lowering infection percentages, and eliminating dead space.
Most commonly, abdominal closed-suction drains are used following autologous breast reconstruction with a DIEP flap to prevent donor site complications such as seroma, hematoma, and wound dehiscence. Although abdominal drains are effective in impeding accumulation, they are a potential portal for infection, Furthermore, they restrict patient mobility, are cumbersome, require time-consuming care upon discharge, potentially increase inpatient stay and ultimately resulting in impaired health-care costs. In the context of an Enhanced Rapid Protocol (ERP), not placing abdominal drains would be a step forward. This involves using "quilting sutures" to close the dead space after flap prelevation. Quilting sutures are placed between the subcutaneous tissues of the abdominal flap and the underlying fascia of the rectus abdominis muscle and aim to minimizes the shearing forces and collapse the death space without the use of drains. Progressive tension sutures were first described in 2000, in a retrospective paper on cosmetic abdominoplasty patients. Since then, their procedure has been analysed and adapted by many authors and applied in perforator-based abdominal flaps for breast reconstruction.
Despite the drainless approach is well known in the literature for cosmetic abdominoplasty procedures, prospective clinical investigations to encourage the drainless approach in DIEP flap reconstruction is lacking. Therefore we want to set up a prospective study to make a comparison between the outcomes succeeding donor site closure after DIEP flap harvesting with (AD) or without (W-AD) the use of abdominal drains and investigate whether there is a correlation between the use of drains and the length of hospital stay. Secondary outcomes involve the complication rate of seroma, hematoma, and dehiscence analysis of abdominal drain output and postoperative recovery, including pain and follow-up complications as described above.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
Felix De Bruyn, Medical doctor
CONTACT
Felix De Bruyn, Medical doctor
PRINCIPAL_INVESTIGATOR
Julie Paternoster, Medical doctor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will undergo a breast reconstruction with a DIEP flap without the placement of drains.
Patients will undergo a breast reconstruction with a DIEP flap with the placement of drains.
Time frame: During admission to the hospital
Length of hospital stay (LOS) is the same or less in patients without abdominal drains versus patients with drains
Time frame: from enrollment until study completion, an average of 1 year
Complications (hematoma, seroma, wound dehiscence, wound infection) are the same or less in patients without abdominal drains versus patients with drains
Time frame: from enrollment until study completion, an average of 1 year
We will investigate if pain is the same or less in patiens without abdominal drains versus patients with drains. We will use the VAS (visual analogue scale)
Time frame: from enrollment until study completion, an average of 1 year
We will investigate if patient satisfaction is the same or less in patients without abdominal drains versus patients with drains. We will use the breast Q queestionnaire..
Contact information is provided by the study sponsor or research team.
Felix De Bruyn, Medical doctor
CONTACT
Julie Paternoster, Medical doctor
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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