Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator (DIEP) Flap on Complications and Duration of Hospital Stay.
NCT Number: NCT06468488
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Reconstruction
Interventions: PROCEDURE: DIEP flap surgery without drain|PROCEDURE: DIEP flap surgery with drains
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-08
Locations: Uz Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

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 \&#34;quilting sutures\&#34; 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.

Primary Outcome Measures: 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 Outcome Measures: 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|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|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