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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01942707
Other study ID # INFORZATO55
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 11, 2013
Last updated March 1, 2018
Start date March 2013
Est. completion date December 2018

Study information

Verified date March 2018
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 46
Est. completion date December 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender Female
Age group 24 Years to 55 Years
Eligibility Inclusion Criteria:

- BMI between 22 and 30 Kg/m2

- Female post-bariatric patient

Exclusion Criteria:

- neoplasms

- Diabetes

- lymphatic system diseases

- abdominal scars except C section and bariatric surgery scars

- mental disorders

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
abdominoplasty with Scarpa`s Fascia
During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
Abdominoplasty without Scarpa´s Facia
During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.

Locations

Country Name City State
Brazil Federal University of São Paulo São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (29)

Andrades 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):935-46; discussion 947-51. — View Citation

Andrades P, Prado A. Composition of postabdominoplasty seroma. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):514-8. Epub 2007 Jul 20. — View Citation

Baroudi R, Ferreira CA. Seroma: how to avoid it and how to treat it. Aesthet Surg J. 1998 Nov-Dec;18(6):439-41. — View Citation

Bercial 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. — View Citation

Buchwald 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. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View Citation

Bussolaro 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. — View Citation

Colquitt J, Clegg A, Loveman E, Royle P, Sidhu MK. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD003641. Review. Update in: Cochrane Database Syst Rev. 2009;(2):CD003641. — View Citation

Costa 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. — View Citation

Costa-Ferreira A, Rebelo M, Vásconez LO, Amarante J. Scarpa fascia preservation during abdominoplasty: a prospective study. Plast Reconstr Surg. 2010 Apr;125(4):1232-9. doi: 10.1097/PRS.0b013e3181d0ac59. — View Citation

Dellon AL. Fleur-de-lis abdominoplasty. Aesthetic Plast Surg. 1985;9(1):27-32. — View Citation

Di Martino M, Nahas FX, Barbosa MV, 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):1742-51. doi: 10.1097/PRS.0b013e3181efa6c5. — View Citation

Farah 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. — View Citation

Fraccalvieri 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. — View Citation

García-García ML, Martín-Lorenzo JG, Campillo-Soto A, Torralba-Martínez JA, Lirón-Ruiz R, Miguel-Perelló 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. — View Citation

Gloy 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. Review. — View Citation

James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. Review. — View Citation

Koller M, Hintringer T. Scarpa fascia or rectus fascia in abdominoplasty flap elevation: a prospective clinical trial. Aesthetic Plast Surg. 2012 Apr;36(2):241-3. doi: 10.1007/s00266-011-9795-8. Epub 2011 Aug 19. — View Citation

Le Louarn C. Partial subfascial abdominoplasty. Aesthetic Plast Surg. 1996 Mar-Apr;20(2):123-7. — View Citation

Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 Apr 5;142(7):547-59. — View Citation

Mohammad JA, Warnke PH, Stavraky W. Ultrasound in the diagnosis and management of fluid collection complications following abdominoplasty. Ann Plast Surg. 1998 Nov;41(5):498-502. — View Citation

Montano-Pedroso JC, Garcia EB, Omonte IR, Rocha MG, Ferreira LM. Hematological variables and iron status in abdominoplasty after bariatric surgery. Obes Surg. 2013 Jan;23(1):7-16. doi: 10.1007/s11695-012-0720-2. — View Citation

Nahas FX, di Martino M, Ferreira LM. Fibrin glue as a substitute for quilting suture in abdominoplasty. Plast Reconstr Surg. 2012 Jan;129(1):212e-213e. doi: 10.1097/PRS.0b013e3182365d65. — View Citation

Nahas FX, Ferreira LM, Ghelfond C. Does quilting suture prevent seroma in abdominoplasty? Plast Reconstr Surg. 2007 Mar;119(3):1060-4; discussion 1065-6. — View Citation

Neaman KC, Hansen JE. Analysis of complications from abdominoplasty: a review of 206 cases at a university hospital. Ann Plast Surg. 2007 Mar;58(3):292-8. Review. — View Citation

Persichetti P, Simone P, Scuderi N. Anchor-line abdominoplasty: a comprehensive approach to abdominal wall reconstruction and body contouring. Plast Reconstr Surg. 2005 Jul;116(1):289-94. — View Citation

Pitanguy I. Evaluation of body contouring surgery today: a 30-year perspective. Plast Reconstr Surg. 2000 Apr;105(4):1499-514; discussion 1515-6. — View Citation

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 Mar;62(3):240-3. doi: 10.1097/SAP.0b013e318180c8e2. — View Citation

Saldanha OR, Federico R, Daher PF, Malheiros AA, Carneiro PR, Azevedo SF, Saldanha Filho OR, Saldanha CB. Lipoabdominoplasty. Plast Reconstr Surg. 2009 Sep;124(3):934-42. doi: 10.1097/PRS.0b013e3181b037e3. — View Citation

Stewart KJ, Stewart DA, Coghlan B, Harrison DH, Jones BM, Waterhouse N. Complications of 278 consecutive abdominoplasties. J Plast Reconstr Aesthet Surg. 2006;59(11):1152-5. Epub 2006 Jul 5. Review. — View Citation

* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Secondary 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. Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days
Secondary 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. Done after 20 days of surgery
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