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NCT Number: NCT06468488

Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator (DIEP) Flap on Complications and Duration of Hospital Stay.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Uz Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location contact

Felix De Bruyn, Medical doctor

CONTACT

[email protected]

0479931742

Felix De Bruyn, Medical doctor

PRINCIPAL_INVESTIGATOR

Julie Paternoster, Medical doctor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent must be obtained prior to any screening procedures
  • Gender: female
  • Age >18 years old
  • Breast cancer for which mastectomy is planned (primary case) OR patient has already had mastectomy (secondary case)
  • Wish to have a DIEP flap procedure (uni-or bilateral) for breast reconstruction
  • Meets criteria for DIEP flap procedure (no previous open abdominal surgery)
  • Pre- and postoperative smoking cessation of 3 months

Exclusion criteria

  • Patient has history of open abdominal surgery wich compromises blood flow to DIEP flap
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
  • No informed consent
  • Age < 18 years old
  • Currently smoking or cessation <3 months preoperatively
  • The use of immunosuppressive drugs
  • Other ongoing therapies which might compromise normal postoperative course (e.g. chemotherapy, radiotherapy, …)

Treatment and study plan

DIEP flap surgery without drain

Procedure

Patients will undergo a breast reconstruction with a DIEP flap without the placement of drains.

DIEP flap surgery with drains

Procedure

Patients will undergo a breast reconstruction with a DIEP flap with the placement of drains.

Primary outcomes

  1. Length of stay (LOS)

    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

Secondary outcomes

  1. Complication rate

    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

  2. Pain (VAS)

    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)

  3. Patient satisfaction (Breast Q)

    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..

Study contacts

Contact information is provided by the study sponsor or research team.

Felix De Bruyn, Medical doctor

CONTACT

[email protected]

+32479931742

Julie Paternoster, Medical doctor

CONTACT

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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