SeromaNCT01942707
Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
A study testing abdominoplasty with Scarpa's Fascia and Abdominoplasty without Scarpa´s Facia in people with Seroma, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. Read more about this study
- Who is it for?
- Ages 24 to 55 years, women only
- Conditions the study is for
- Seroma
- What is being tested?
- abdominoplasty with Scarpa's Fascia and Abdominoplasty without Scarpa´s Facia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI between 22 and 30 Kg/m2
- Female post-bariatric patient
Who cannot join
- neoplasms
- Diabetes
- lymphatic system diseases
- abdominal scars except C section and bariatric surgery scars
- mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
Read the detailed description
Morbid obesity has been increasing in Brazil and the world and bariatric surgery is the most effective and long-lasting treatment. This leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. The most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. PURPOSE: To evaluate the effect of Scarpa fascia preservation in seroma reduction. METHODS: A total of 46 patients were randomly assigned to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
- Conditions
- Seroma
- Being tested
- abdominoplasty with Scarpa's Fascia, Abdominoplasty without Scarpa´s Facia
- Keywords
- Abdominoplasty,Seroma,Bariatric surgery
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominoplasty with Scarpa's FasciaProcedure or surgery
During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
Abdominoplasty without Scarpa´s FaciaProcedure or surgery
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.
| Study group | Role | What they receive |
|---|---|---|
| Abdominoplasty without Scarpa´s Facia | Active comparator | Anchor-line abdominoplasty where the Scarpa's Fascia will be removed. Receives: Procedure: Abdominoplasty without Scarpa´s Facia |
| abdominoplasty with Scarpa's Fascia | Experimental | Anchor-line abdominoplasty where the Scarpa's Fascia will be preserved. Receives: Procedure: abdominoplasty with Scarpa's Fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume of Drainage in ml.
We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.
Measured: number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Secondary outcomes (2)
Number of Days Required for Drain Withdrawal.
Number of days required for drain withdrawal. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.
Measured: Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.
An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.
Measured: Done after 20 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heraldo Carlos Borges, Federal University of São Paulo
- Investigators
- Lydia M Ferreira, MD, Phd, Study chair, Federal University of São PauloJuan C Montano-Pedroso, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942707
- Sponsor's protocol ID
- INFORZATO55
- Status last verified
- Mar 2018
- First submitted
- 11 Sep 2013
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Andrades P, Prado A. Composition of postabdominoplasty seroma. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):514-8. doi: 10.1007/s00266-007-0078-3. Epub 2007 Jul 20.
PubMed 17659406Andrades P, Prado A, Danilla S, Guerra C, Benitez S, Sepulveda S, Sciarraffia C, De Carolis V. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007 Sep 15;120(4):935-946. doi: 10.1097/01.prs.0000253445.76991.de.
PubMed 17805122Baroudi R, Ferreira CA. Seroma: how to avoid it and how to treat it. Aesthet Surg J. 1998 Nov-Dec;18(6):439-41. doi: 10.1016/s1090-820x(98)70073-1.
PubMed 19328174Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Bussolaro RA, Garcia EB, Zanella MT, Ferreira LM. Impaired abdominal skin sensory function in morbid obesity and after bariatric surgery. Obes Surg. 2012 Mar;22(3):353-9. doi: 10.1007/s11695-011-0485-z.
PubMed 21805192Bercial ME, Sabino Neto M, Calil JA, Rossetto LA, Ferreira LM. Suction drains, quilting sutures, and fibrin sealant in the prevention of seroma formation in abdominoplasty: which is the best strategy? Aesthetic Plast Surg. 2012 Apr;36(2):370-3. doi: 10.1007/s00266-011-9807-8. Epub 2011 Aug 20.
PubMed 21858593Colquitt J, Clegg A, Loveman E, Royle P, Sidhu MK. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD003641. doi: 10.1002/14651858.CD003641.pub2.
PubMed 16235331Costa LF, Landecker A, Manta AM. Optimizing body contour in massive weight loss patients: the modified vertical abdominoplasty. Plast Reconstr Surg. 2004 Dec;114(7):1917-23; discussion 1924-6. doi: 10.1097/01.prs.0000142997.63346.95.
PubMed 15577368Dellon AL. Fleur-de-lis abdominoplasty. Aesthetic Plast Surg. 1985;9(1):27-32. doi: 10.1007/BF01570680.
PubMed 3158172Di Martino M, Nahas FX, Barbosa MVJ, Montecinos Ayaviri NA, Kimura AK, Barella SM, Novo NF, Ferreira LM. Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg. 2010 Nov;126(5):1742-1751. doi: 10.1097/PRS.0b013e3181efa6c5.
PubMed 20639797Costa-Ferreira A, Rebelo M, Vasconez LO, Amarante J. Scarpa fascia preservation during abdominoplasty: a prospective study. Plast Reconstr Surg. 2010 Apr;125(4):1232-1239. doi: 10.1097/PRS.0b013e3181d0ac59.
PubMed 20072084Farah AB, Nahas FX, Ferreira LM, Mendes Jde A, Juliano Y. Sensibility of the abdomen after abdominoplasty. Plast Reconstr Surg. 2004 Aug;114(2):577-82; discussion 583. doi: 10.1097/01.prs.0000128356.93462.7b.
PubMed 15277836Fraccalvieri M, Datta G, Bogetti P, Verna G, Pedrale R, Bocchiotti MA, Boriani F, Obbialero FD, Kefalas N, Bruschi S. Abdominoplasty after weight loss in morbidly obese patients: a 4-year clinical experience. Obes Surg. 2007 Oct;17(10):1319-24. doi: 10.1007/s11695-007-9235-7.
PubMed 18000727Garcia-Garcia ML, Martin-Lorenzo JG, Campillo-Soto A, Torralba-Martinez JA, Liron-Ruiz R, Miguel-Perello J, Mengual-Ballester M, Aguayo-Albasini JL. [Complications and level of satisfaction after dermolipectomy and abdominoplasty post-bariatric surgery]. Cir Esp. 2014 Apr;92(4):254-60. doi: 10.1016/j.ciresp.2013.04.024. Epub 2013 Dec 18. Spanish.
PubMed 24360407Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934.
PubMed 24149519
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01942707
- Acronym / sponsor ID
- INFORZATO55
- Conditions
- Seroma
- Keywords
- Abdominoplasty,Seroma,Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Posted 3 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
Detailed description
Morbid obesity has been increasing in Brazil and the world and bariatric surgery is the most effective and long-lasting treatment. This leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. The most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. PURPOSE: To evaluate the effect of Scarpa fascia preservation in seroma reduction. METHODS: A total of 46 patients were randomly assigned to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominoplasty without Scarpa´s Facia | Active comparator | Procedure: Abdominoplasty without Scarpa´s FaciaAnchor-line abdominoplasty where the Scarpa's Fascia will be removed. |
| abdominoplasty with Scarpa's Fascia | Experimental | Procedure: abdominoplasty with Scarpa's FasciaAnchor-line abdominoplasty where the Scarpa's Fascia will be preserved. |
Who may qualify
- Ages
- 24 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 22 and 30 Kg/m2
- Female post-bariatric patient
Key exclusion criteria (5 listed)
- neoplasms
- Diabetes
- lymphatic system diseases
- abdominal scars except C section and bariatric surgery scars
- mental disorders
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 |
|---|---|---|
| abdominoplasty with Scarpa's FasciaDuring surgical detachment of the abdominal flap the Scarpa´s fascia is preserved. | Procedure or surgery | abdominoplasty with Scarpa's Fascia |
| Abdominoplasty without Scarpa´s FaciaDuring surgical detachment of the abdominal flap the Scarpa´s fascia is removed. | Procedure or surgery | Abdominoplasty without Scarpa´s Facia |
Primary outcome
Total Volume of Drainage in ml.
Time frame: number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.
2 secondary outcomes
Number of Days Required for Drain Withdrawal.
Time frame: Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.
Time frame: Done after 20 days of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17659406Andrades P, Prado A. Composition of postabdominoplasty seroma. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):514-8. doi: 10.1007/s00266-007-0078-3. Epub 2007 Jul 20.
- Background: PubMed 17805122Andrades P, Prado A, Danilla S, Guerra C, Benitez S, Sepulveda S, Sciarraffia C, De Carolis V. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007 Sep 15;120(4):935-946. doi: 10.1097/01.prs.0000253445.76991.de.
- Background: PubMed 19328174Baroudi R, Ferreira CA. Seroma: how to avoid it and how to treat it. Aesthet Surg J. 1998 Nov-Dec;18(6):439-41. doi: 10.1016/s1090-820x(98)70073-1.
- Background: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Background: PubMed 21805192Bussolaro RA, Garcia EB, Zanella MT, Ferreira LM. Impaired abdominal skin sensory function in morbid obesity and after bariatric surgery. Obes Surg. 2012 Mar;22(3):353-9. doi: 10.1007/s11695-011-0485-z.
- Background: PubMed 21858593Bercial ME, Sabino Neto M, Calil JA, Rossetto LA, Ferreira LM. Suction drains, quilting sutures, and fibrin sealant in the prevention of seroma formation in abdominoplasty: which is the best strategy? Aesthetic Plast Surg. 2012 Apr;36(2):370-3. doi: 10.1007/s00266-011-9807-8. Epub 2011 Aug 20.
- Background: PubMed 16235331Colquitt J, Clegg A, Loveman E, Royle P, Sidhu MK. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD003641. doi: 10.1002/14651858.CD003641.pub2.
- Background: PubMed 15577368Costa LF, Landecker A, Manta AM. Optimizing body contour in massive weight loss patients: the modified vertical abdominoplasty. Plast Reconstr Surg. 2004 Dec;114(7):1917-23; discussion 1924-6. doi: 10.1097/01.prs.0000142997.63346.95.
- Background: PubMed 3158172Dellon AL. Fleur-de-lis abdominoplasty. Aesthetic Plast Surg. 1985;9(1):27-32. doi: 10.1007/BF01570680.
- Background: PubMed 20639797Di Martino M, Nahas FX, Barbosa MVJ, Montecinos Ayaviri NA, Kimura AK, Barella SM, Novo NF, Ferreira LM. Seroma in lipoabdominoplasty and abdominoplasty: a comparative study using ultrasound. Plast Reconstr Surg. 2010 Nov;126(5):1742-1751. doi: 10.1097/PRS.0b013e3181efa6c5.
- Background: PubMed 20072084Costa-Ferreira A, Rebelo M, Vasconez LO, Amarante J. Scarpa fascia preservation during abdominoplasty: a prospective study. Plast Reconstr Surg. 2010 Apr;125(4):1232-1239. doi: 10.1097/PRS.0b013e3181d0ac59.
- Background: PubMed 15277836Farah AB, Nahas FX, Ferreira LM, Mendes Jde A, Juliano Y. Sensibility of the abdomen after abdominoplasty. Plast Reconstr Surg. 2004 Aug;114(2):577-82; discussion 583. doi: 10.1097/01.prs.0000128356.93462.7b.
- Individual participant dataSharing planned: No
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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.
Lydia M Ferreira, MD, Phd study chair
Federal University of São Paulo
Juan C Montano-Pedroso, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominoplasty with Scarpa's Fascia and Abdominoplasty without Scarpa´s Facia in people with Seroma, run by Federal University of São Paulo at 1 site in Brazil.
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 2 inclusion and 5 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 29 Mar 2018. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Volume of Drainage in ml. (time frame: number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 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 NCT01942707, which also lists 29 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 29 Mar 2018.