Breast ReconstructionNCT06468488
Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator (DIEP) Flap on Complications and Duration of Hospital Stay.
A study testing DIEP flap surgery without drain and DIEP flap surgery with drains in people with Breast Reconstruction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- DIEP flap surgery without drain and DIEP flap surgery with drains
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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, …)
Trial locations and contacts
1 site in 1 country.
Julie Paternoster, Medical doctor contact
Belgium1 site
Uz Leuven
Leuven, Vlaams-Brabant, 3000
Felix De Bruyn, Medical doctor, 0479931742, felixdebruyn@hotmail.com
Julie Paternoster, Medical doctor, felixdebruyn@hotmail.com
About this study
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.
- Conditions
- Breast Reconstruction
- Being tested
- DIEP flap surgery without drain, DIEP flap surgery with drains
- Keywords
- Breast reconstruction, DIEP, Drainless
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIEP flap surgery without drainProcedure or surgery
Patients will undergo a breast reconstruction with a DIEP flap without the placement of drains.
DIEP flap surgery with drainsProcedure or surgery
Patients will undergo a breast reconstruction with a DIEP flap with the placement of drains.
| Study group | Role | What they receive |
|---|---|---|
| DIEP flap surgery with drains | Active comparator | Patients will undergo a breast reconstruction by a DIEP flap with drains. Receives: Procedure: DIEP flap surgery with drains |
| DIEP flap surgery without drains | Experimental | Patients will undergo a breast reconstruction by a DIEP flap without drains. Receives: Procedure: DIEP flap surgery without drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS)
Length of hospital stay (LOS) is the same or less in patients without abdominal drains versus patients with drains
Measured: During admission to the hospital
Secondary outcomes (3)
Complication rate
Complications (hematoma, seroma, wound dehiscence, wound infection) are the same or less in patients without abdominal drains versus patients with drains
Measured: 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)
Measured: 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..
Measured: from enrollment until study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non blindend randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Debruyn, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468488
- Sponsor's protocol ID
- S68700
- Status last verified
- Jun 2024
- First submitted
- 26 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator (DIEP) Flap on Complications and Duration of Hospital Stay.
- ClinicalTrials.gov ID
- NCT06468488
- Acronym / sponsor ID
- S68700
- Conditions
- Breast Reconstruction
- Keywords
- Breast reconstruction, DIEP, Drainless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non blindend randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| DIEP flap surgery with drains | Active comparator | Procedure: DIEP flap surgery with drainsPatients will undergo a breast reconstruction by a DIEP flap with drains. |
| DIEP flap surgery without drains | Experimental | Procedure: DIEP flap surgery without drainPatients will undergo a breast reconstruction by a DIEP flap without drains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIEP flap surgery without drainPatients will undergo a breast reconstruction with a DIEP flap without the placement of drains. | Procedure or surgery | DIEP flap surgery without drains |
| DIEP flap surgery with drainsPatients will undergo a breast reconstruction with a DIEP flap with the placement of drains. | Procedure or surgery | DIEP flap surgery with drains |
Primary outcome
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
3 secondary outcomes
Complication rate
Time frame: from enrollment until study completion, an average of 1 year
Pain (VAS)
Time frame: from enrollment until study completion, an average of 1 year
Patient satisfaction (Breast Q)
Time frame: from enrollment until study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Paternoster, Medical doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIEP flap surgery without drain and DIEP flap surgery with drains in people with Breast Reconstruction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix De Bruyn, Medical doctor (+32479931742, felixdebruyn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (LOS) (time frame: During admission to the hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.