Effect of Irrigation of Triamcinolone Versus Hypertonic Saline in Decreasing Seroma Post Abdominoplasty

NCT07733921 | Completed

• 1 other identifier: MD-468-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 90 abdominoplasty patients were randomly assigned into three groups: Group A: Triamcinolone group, Group B: Hypertonic saline group, Group C: Control group Randomization: It was performed using the closed envelope technique. Technique: After performing a Lipo-abdominoplasty Group A (triamcinolone) irrigates 10 cm saline mixed with two 40 mg vials through the umbilicus into dead space; Group B (hypertonic saline) irrigates 20 cm of 10% solution similarly; Group C (control) receives no irrigation

Conditions

Seroma Formation

Keywords

Triamcinolone; hypertonic saline; Lipo-abdominoplasty; seroma; drain output

Outcome Measures

Primary Outcomes (2)

• number of abdominoplasty patients having seroma after intraoperative Triamcinolone irrigation

  number of patients having seroma after irrigation of 10 cc of saline 0.9% mixed with 80 mg triamcinolone

  8 weeks

• number of abdominoplasty patients having seroma after intraoperative hypertonic saline irrigation

  number of patients having seroma after irrigation of 20cc of 10% hypertonic saline

  8 weeks

Secondary Outcomes (6)

• days needed to remove the drain post abdominoplasty after intraoperative triamcinolone irrigation

  up to 15 days

• Days needed to remove the drain post abdominoplasty after intraoperative Hypertonic saline irrigation

  Up to 15 days

• total amount of seroma, measured in cc, in patients who develop seroma after intraoperative Triamcinolone irrigation following abdominoplasty

  8 weeks

• total amount of seroma, measured in cc, in patients who develop seroma after intraoperative hypertonic saline irrigation following abdominoplasty

  8 weeks

• total drain output, measured in cc, post abdominoplasty after intraoperative triamcinolone irrigation

  up to 15 days

Study Arms (3)

Group A Triamcinolone group

ACTIVE COMPARATOR

Irrigation of Triamcinolone post lipo-abdominoplasty 10cc normal saline 0.9% with 80mg of Triamcinolone

Drug: Irrigation of Triamcinolone

Group B Hypertonic saline

ACTIVE COMPARATOR

Irrigation of Hypertonic Saline post lipo-abdominoplasty 20cc of 10% Hypertonic Saline

Drug: Hypertonic Saline 10%

Group C Control Group

PLACEBO COMPARATOR

Lipo-Abdominoplasty

Drug: Control

Interventions

Irrigation of Triamcinolone DRUG

Irrigation of Triamcinolone 80 mg post abdominoplasty to decrease the incidence of seroma and allow early drain removal

Group A Triamcinolone group

Hypertonic Saline 10% DRUG

Irrigation of Hypertonic saline 10%

Group B Hypertonic saline

Control DRUG

Control Group with no irrigation

Group C Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• Age: 18-65
• BMI ≤ 39
• Pendulous abdomen grades 3 and 4 according to the Matarasso classification of 1991.

You may not qualify if:

• Age: \< 18 years and \> 65 years
• BMI: \>39.1
• Known allergies to steroidal compounds
• Uncontrolled medical comorbidities
• open abdominal surgeries other than caesarian sections.
• Ventral hernias
• Ehlers-Danlos and other hyper elasticity syndromes

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, 11956, Egypt

Location

Related Publications (13)

• Wang Y, Xie S. Intraoperative Hypertonic Saline Irrigation Preventing Seroma Formation in the Treatment of Axillary Bromhidrosis. Aesthetic Plast Surg. 2024 Sep;48(17):3216-3221. doi: 10.1007/s00266-024-03987-2. Epub 2024 May 8.

  PMID: 38720102 BACKGROUND

• Dudai M, Gilboa Ittah K. Intraoperative hypertonic saline irrigation preventing seroma formation and reducing drain secretion in extended endoscopic hernia and linea alba reconstruction glue. Hernia. 2019 Dec;23(6):1291-1296. doi: 10.1007/s10029-019-01956-2. Epub 2019 May 4.

  PMID: 31055707 BACKGROUND

• Anker AM, Lenhard J, Klein SM, Felthaus O, Prantl L, Ruewe M. Standard doses of Triamcinolone do not affect fibroblast cell migration of abdominoplasty patients in-vitro1. Clin Hemorheol Microcirc. 2023;85(3):307-314. doi: 10.3233/CH-229106.

  PMID: 36502314 BACKGROUND

• Hart AM, Duggal C, Pinell-White X, Losken A. A Prospective Randomized Trial of the Efficacy of Fibrin Glue, Triamcinolone Acetonide, and Quilting Sutures in Seroma Prevention after Latissimus Dorsi Breast Reconstruction. Plast Reconstr Surg. 2017 Apr;139(4):854e-863e. doi: 10.1097/PRS.0000000000003213.

  PMID: 28350654 BACKGROUND

• Qvamme G, Axelsson CK, Lanng C, Mortensen M, Wegeberg B, Okholm M, Arpi MR, Szecsi PB. Randomized clinical trial of prevention of seroma formation after mastectomy by local methylprednisolone injection. Br J Surg. 2015 Sep;102(10):1195-203. doi: 10.1002/bjs.9874. Epub 2015 Jul 14.

  PMID: 26179672 BACKGROUND

• Bromley M, Marrou W, Charles-de-Sa L. Evaluation of the Number of Progressive Tension Sutures Needed to Prevent Seroma in Abdominoplasty with Drains: A Single-Blind, Prospective, Comparative, Randomized Clinical Trial. Aesthetic Plast Surg. 2018 Dec;42(6):1600-1608. doi: 10.1007/s00266-018-1227-6. Epub 2018 Sep 26.

  PMID: 30259166 BACKGROUND

• Anker AM, Felthaus O, Prantl L, Geis S, Brebant V, Kehrer A, Strauss C, Ruewe M, Vykoukal J, Klein SM. Local Triamcinolone Treatment Affects Inflammatory Response in Seroma Exudate of Abdominoplasty Patients: A Randomized Controlled Trial. Plast Reconstr Surg. 2021 Feb 1;147(2):345-354. doi: 10.1097/PRS.0000000000007523.

  PMID: 33565825 BACKGROUND

• Zhang L, Mendoza-Sassi RA, Wainwright CE, Aregbesola A, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2023 Apr 4;4(4):CD006458. doi: 10.1002/14651858.CD006458.pub5.

  PMID: 37014057 BACKGROUND

• Bhosale R, Dawar R, Manas RK. Role of Triamcinolone Acetonide in the Maturation of Scars. Plast Reconstr Surg Glob Open. 2024 Jul 15;12(7):e5966. doi: 10.1097/GOX.0000000000005966. eCollection 2024 Jul.

  PMID: 39015354 BACKGROUND

• Seretis K, Goulis D, Demiri EC, Lykoudis EG. Prevention of Seroma Formation Following Abdominoplasty: A Systematic Review and Meta-Analysis. Aesthet Surg J. 2017 Mar 1;37(3):316-323. doi: 10.1093/asj/sjw192.

  PMID: 28158391 BACKGROUND

• Liao CD, Zhao K, Nikkhahmanesh N, Bui DT. Decreasing Seroma Incidence Following Abdominoplasty: A Systematic Review and Meta-Analysis of High-Quality Evidence. Aesthet Surg J Open Forum. 2024 Mar 16;6:ojae016. doi: 10.1093/asjof/ojae016. eCollection 2024.

  PMID: 38585023 BACKGROUND

• Salari N, Fatahi B, Bartina Y, Kazeminia M, Heydari M, Mohammadi M, Hemmati M, Shohaimi S. The Global Prevalence of Seroma After Abdominoplasty: A Systematic Review and Meta-Analysis. Aesthetic Plast Surg. 2021 Dec;45(6):2821-2836. doi: 10.1007/s00266-021-02365-6. Epub 2021 Jun 2.

  PMID: 34080041 BACKGROUND

• Saldanha OR, Pinto EB, Matos WN Jr, Lucon RL, Magalhaes F, Bello EM. Lipoabdominoplasty without undermining. Aesthet Surg J. 2001 Nov;21(6):518-26. doi: 10.1067/maj.2001.121243.

  PMID: 19331937 BACKGROUND

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Of Plastic & Reconstructive Surgery

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 29, 2026
• Study Start: November 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)