SeromaPhase 1STRAMQUSGNCT01358786
Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound
A Phase 1 study testing quilting suture in people with Seroma, run by Federal University of São Paulo.
Trial summary
Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are used for membership (between the aponeurosis of the abdominal flap and underlying muscles) for closing the donor area, where there is reduced incidence of complications. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Seroma
- What is being tested?
- quilting suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Oct 2010
- Phase
- Phase 1
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were age between 20 and 65 years
- body mass index (BMI) ≤ 30 kg/m2
- non-smokers.
Who cannot join
- no skin excess in the infraumbilical region
- previous abdominoplasty
- uncontrolled systemic disease
- such as diabetes mellitus and arterial hypertension
- collagen diseases
- psychiatric disorders
- large weight loss
- and/or postoperative abdominal scars that could hinder flap vascularization.
About this study
Official title: Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture.
Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are used for membership (between the aponeurosis of the abdominal flap and underlying muscles) for closing the donor area, where there is reduced incidence of complications.
Read the detailed description
This study evaluated seroma formation at the donor site of the TRAM patients who underwent breast reconstruction. Forty-eight breast reconstructions were performed using the bipedicled TRAM flap. The patients were randomly allocated into three groups of 16 participants each: DN group, use of suction drains but no quilting sutures between the remaining abdominal flap and musculoaponeurotic layer of the anterior abdominal wall; QS+DN group, use of quilting sutures and suction drains; and QS group, use of quilting sutures but no suction drains. In order to determine seroma formation, ultrasound examinations were performed on postoperative days 7 and 14 in 5 regions of the abdominal wall: epigastric, umbilical, hypogastric, right iliac, and left iliac regions.
- Conditions
- Seroma
- Being tested
- quilting suture
- Keywords
- Quilting suture, seroma, Procedure, Surgery
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quilting sutureProcedure or surgery
Also called points
- quilting sutures and drains
- quilting sutures but no drains
| Study group | Role | What they receive |
|---|---|---|
| no quilting sutures but drains | No intervention | Not described Receives: Procedure: quilting suture |
| quilting sutures and drains | Experimental | Not described Receives: Procedure: quilting suture |
| quilting sutures but no drains | Experimental | Not described Receives: Procedure: quilting suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing seroma in donor site of the TRAM flap
Seroma formation was identified clinically and confirmed by ultrasound examination. Clinical examination consisted of evaluation of early symptoms (bulging and distension of the skin, signs of fluid accumulation), palpation, and percussion. Ultrasound examination was performed on postoperative days 7 and 14 to detect the presence of seroma at the TRAM flap donor site. The patients were placed in the supine position during the examination. Upon detection of seroma, ultrasound-guided puncture was performed, and the number of punctures and volume of seroma aspirated were recorded.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startApr 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SeromaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- luis Rossetto, MD, Study director, Graduate Program in Plastic Surgery, School of Medicine, Universidade Federal de São PaConception and design of the study, drafting the article, revising it critically for important intellectual content, and final approval of the version to be submitted.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358786
- Sponsor's protocol ID
- CEP 1995 08
- Other IDs
- CEP 1995/08
- Acronym
- STRAMQUSG
- Status last verified
- Jun 2009
- First submitted
- 16 May 2011
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Hartrampf CR, Jr, Scheflan M, Black PW. Breast reconstruction with a transverse abdominal island flap. Plast Reconstr Surg. 1982;69:216-225. 2. Andrades P, Prado A, Danilla S, et al. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007;120:935-946. 3. Baroudi R, Ferreira CA. Contouring the hip and the abdomen. Clin Plast Surg. 1996;23:551-572. 4. Rossetto LA, Garcia EB, Abla LF, Neto MS, Ferreira LM. Quilting suture in the donor site of the transverse rectus abdominis musculocutaneous flap in breast reconstruction. Ann Plast Surg. 2009;62:240-243. %. Di Martino M, Nahas FX, Barbosa MV, et al. Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg. 2010;126:1742-1751.
Rossetto LA, Garcia EB, Abla LE, Ferreira LM. Seroma and quilting suture at the donor site of the TRAM flap in breast reconstruction: a prospective randomized double-blind clinical trial. Ann Plast Surg. 2014 Apr;72(4):391-7. doi: 10.1097/SAP.0b013e3182610b11.
PubMed 23407260
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture.
- ClinicalTrials.gov ID
- NCT01358786
- Acronym / sponsor ID
- STRAMQUSG / CEP 1995 08
- Conditions
- Seroma
- Keywords
- Quilting suture, seroma, Procedure, Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 May 2011 (estimated)
- 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.
Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are used for membership (between the aponeurosis of the abdominal flap and underlying muscles) for closing the donor area, where there is reduced incidence of complications.
Detailed description
This study evaluated seroma formation at the donor site of the TRAM patients who underwent breast reconstruction. Forty-eight breast reconstructions were performed using the bipedicled TRAM flap. The patients were randomly allocated into three groups of 16 participants each: DN group, use of suction drains but no quilting sutures between the remaining abdominal flap and musculoaponeurotic layer of the anterior abdominal wall; QS+DN group, use of quilting sutures and suction drains; and QS group, use of quilting sutures but no suction drains. In order to determine seroma formation, ultrasound examinations were performed on postoperative days 7 and 14 in 5 regions of the abdominal wall: epigastric, umbilical, hypogastric, right iliac, and left iliac regions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no quilting sutures but drains | No intervention | Procedure: quilting suture |
| quilting sutures and drains | Experimental | Procedure: quilting suture |
| quilting sutures but no drains | Experimental | Procedure: quilting suture |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- were age between 20 and 65 years
- body mass index (BMI) ≤ 30 kg/m2
- non-smokers.
Key exclusion criteria (8 listed)
- no skin excess in the infraumbilical region
- previous abdominoplasty
- uncontrolled systemic disease
- such as diabetes mellitus and arterial hypertension
- collagen diseases
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 |
|---|---|---|
| quilting sutureAlso: points* quilting sutures and drains * quilting sutures but no drains | Procedure or surgery | no quilting sutures but drains, quilting sutures and drains, quilting sutures but no drains |
Primary outcome
Reducing seroma in donor site of the TRAM flap
Time frame: 15 days
Seroma formation was identified clinically and confirmed by ultrasound examination. Clinical examination consisted of evaluation of early symptoms (bulging and distension of the skin, signs of fluid accumulation), palpation, and percussion. Ultrasound examination was performed on postoperative days 7 and 14 to detect the presence of seroma at the TRAM flap donor site. The patients were placed in the supine position during the examination. Upon detection of seroma, ultrasound-guided puncture was performed, and the number of punctures and volume of seroma aspirated were recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
- Background1. Hartrampf CR, Jr, Scheflan M, Black PW. Breast reconstruction with a transverse abdominal island flap. Plast Reconstr Surg. 1982;69:216-225. 2. Andrades P, Prado A, Danilla S, et al. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007;120:935-946. 3. Baroudi R, Ferreira CA. Contouring the hip and the abdomen. Clin Plast Surg. 1996;23:551-572. 4. Rossetto LA, Garcia EB, Abla LF, Neto MS, Ferreira LM. Quilting suture in the donor site of the transverse rectus abdominis musculocutaneous flap in breast reconstruction. Ann Plast Surg. 2009;62:240-243. %. Di Martino M, Nahas FX, Barbosa MV, et al. Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg. 2010;126:1742-1751.
- Derived from this study: PubMed 23407260Rossetto LA, Garcia EB, Abla LE, Ferreira LM. Seroma and quilting suture at the donor site of the TRAM flap in breast reconstruction: a prospective randomized double-blind clinical trial. Ann Plast Surg. 2014 Apr;72(4):391-7. doi: 10.1097/SAP.0b013e3182610b11.
- Federal University of Saint PaulLink provided by the sponsor.
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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.
luis Rossetto, MD study director
Graduate Program in Plastic Surgery, School of Medicine, Universidade Federal de São PaConception and design of the study, drafting the article, revising it critically for important intellectual content, and final approval of the version to be submitted.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing quilting suture in people with Seroma, run by Federal University of São Paulo.
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 3 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: finished, as of the sponsor's last update on 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing seroma in donor site of the TRAM flap (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01358786, which also lists 2 linked publications.
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 26 May 2011.