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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468488
• Other study ID #: S68700
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Felix De Bruyn, Medical doctor
• Phone: +32479931742
• Email: felixdebruyn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures

2. Gender: female

3. Age >18 years old

4. Breast cancer for which mastectomy is planned (primary case) OR patient has already had mastectomy (secondary case)

5. Wish to have a DIEP flap procedure (uni-or bilateral) for breast reconstruction

6. Meets criteria for DIEP flap procedure (no previous open abdominal surgery)

7. Pre- and postoperative smoking cessation of 3 months

Exclusion Criteria:

1. Patient has history of open abdominal surgery wich compromises blood flow to DIEP flap

2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.

3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.

4. No informed consent

5. Age < 18 years old

6. Currently smoking or cessation <3 months preoperatively

7. The use of immunosuppressive drugs

8. Other ongoing therapies which might compromise normal postoperative course (e.g. chemotherapy, radiotherapy, …)

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Procedure:
• DIEP flap surgery without drain
Patients will undergo a breast reconstruction with a DIEP flap without the placement of drains.
• DIEP flap surgery with drains
Patients will undergo a breast reconstruction with a DIEP flap with the placement of drains.

Locations

Country	Name	City	State
Belgium	Uz Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay (LOS)	Length of hospital stay (LOS) is the same or less in patients without abdominal drains versus patients with drains	During admission to the hospital
Secondary	Complication rate	Complications (hematoma, seroma, wound dehiscence, wound infection) are the same or less in patients without abdominal drains versus patients with drains	from enrollment until study completion, an average of 1 year
Secondary	Pain (VAS)	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)	from enrollment until study completion, an average of 1 year
Secondary	Patient satisfaction (Breast Q)	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..	from enrollment until study completion, an average of 1 year