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Seroma FormationNCT07733921

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

A study testing Irrigation of Triamcinolone and Hypertonic Saline 10% in people with Seroma Formation, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Seroma Formation
What is being tested?
Irrigation of Triamcinolone and Hypertonic Saline 10%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Nov 2023to 1 Aug 2025
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 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine Cairo University

    Cairo, 11956

Other trials in Egypt

About this study

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

Read the detailed description

A total of 90 patients were recruited in this study from November 2023 until July 2025. These patients presented to the outpatient clinic of the Plastic and Reconstructive Surgery Department, Kasr Al ainy Hospital with pendulous abdomen or manifestations of myofascial abdominal laxity and weakness or more commonly, a combination of both. In additions, almost all patients were complaining of localized stubborn fat deposits usually in the flank and epigastric areas that also needed to be addressed.

Randomization:

It was performed using . Opaque, sealed and sequentially numbered envelopes containing group assignments were prepared by an independent participant not enrolled in the study. Each envelope was opened only after a participant enrollment, ensuring allocation concealment and preventing selection bias.

Pre-operative: Before admission, patients were consented on the study methodology and the randomization process. The initial consultation of our patients revolved around the expected procedural details, the preoperative preparatory steps and the post-operative recovery time and details. Afterwards, proper history and examination were conducted along with routine preoperative labs and abdominal ultrasound to detect hernial defects.

Preoperative markings: In the standing position, after proper exposure of the trunk area, Markings of the liposuction area over the back were done. Followed by anterior markings which begins with identifying the anterior midline and marking both linae semilunaris while the patient contracts the rectus abdominis muscles. Next, the lateral ends of the expected abdominal scars are marked at the abdominal fold with the patient flexing the trunk 30 degrees. The midpoint of the proposed incision site is then marked in the midline at 6-8 cm under medium stretch, confirmed at 8-10 cm under maximum stretch. Measurements of 7 cm lateral to the midline at this site and 9 cm from the midline above the umbilicus are taken, ensuring these points coincide during closure for 2 cm abdominal flap medialization. This midpoint connects laterally to the 7 cm marking and then to the proposed incision ends. Using a pinch test, the proposed upper incision is marked in the midline above the umbilicus and connected to the lateral ends of the proposed lower incision. Finally, areas for liposuction in the anterior flanks and epigastrium are marked.

Operative details: The patient is placed prone, sterilized, draped, and positioned in jack-knife for initial preparation, receiving one dose of a 3rd generation cephalosporin. Super wet solution (1 mg adrenaline, 1 mg tranexamic acid, and 10 cc of 2% lidocaine per 500 ml normal saline) is infiltrated via sacral and bra-line access incisions, followed by a 15-minute wait, then liposuction in marked areas using a straight Mercedes-shaped blunt-tipped 4 mm cannula until a desirable pinch is achieved. The patient is turned supine with trunk extension at the hips, re-sterilized, draped, and anterior access incisions made for infiltrating the same super wet solution into flanks and epigastrium, awaiting 15 minutes before liposuction to desirable pinch endpoint. The proposed incision site opens slantingly to preserve fat over anterior superior iliac spines, followed by uniform supra-fascial dissection to the umbilicus; the umbilicus is incised superficially, dissected to the anterior rectus sheath, circled to free its stalk, and a narrow epigastric tunnel elevated supra-fascial along medial rectus borders per Saldanha's technique without wider undermining. Plication of divarication occurs in two layers above and below the umbilicus with PDS 1-0 loop and proline 1-0 if indicated. The patient flexes to 45 degrees for flap excision, with two suction drains placed laterally; the neo-umbilicus is incised appropriately, umbilicus brought up, and closure performed in layers using 0 Vicryl for Scarpa's fascia, 2-0 Vicryl sub-dermally, and 3-0 Monocryl sub-cuticular. Drains are closed, then per group: Group A (triamcinolone) ; Group B (hypertonic saline) ; Group C (control). Doses were used according to best available evidence. The umbilicus secures with 4-0 Vicryl interrupted dermal and 4-0 Monocryl subcuticular skin sutures. A compression garment with underlying foam support are applied immediately

Post-operative sequalae: The patient is transported to the ward in a semi-sitting position and maintained this way until discharge. Drains remain closed for 1 hour postoperatively, then fluid amount and color (categorized as dark red, serosanguineous, or serous) are measured and documented every 12 hours until removal, with patients instructed pre-discharge on consistent drainage collection and measurement, documenting every 12 hours themselves. Early ambulation with regular fluid intake prevents VTE, and chemoprophylaxis starts if indicated per the 2005 Caprini score. The first dressing occurs the next day to detect early liposuction complications, followed by discharge on antibiotics and analgesics. Lymphatic massage begins as early as postoperative day 3.

In cases of seroma: Clinical seromas, diagnosed by palpable bulge or swelling, are addressed and aspirated using a wide bore cannula and 20 cc syringe. The amount of aspirated fluid is documented per session. And the sessions are repeated every 3 to 4 days according to the patient's condition till the seroma is resolved.

Being tested
Irrigation of Triamcinolone, Hypertonic Saline 10%, Control
Keywords
Triamcinolone, hypertonic saline, Lipo-abdominoplasty, seroma, drain output
Medical subject headings
Seroma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irrigation of TriamcinoloneDrug

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

  • Hypertonic Saline 10%Drug

    Irrigation of Hypertonic saline 10%

  • ControlDrug

    Control Group with no irrigation

Study groups in NCT07733921
Study groupRoleWhat they receive
Group A Triamcinolone groupActive comparatorIrrigation of Triamcinolone post lipo-abdominoplasty 10cc normal saline 0.9% with 80mg of Triamcinolone
Receives: Drug: Irrigation of Triamcinolone
Group B Hypertonic salineActive comparatorIrrigation of Hypertonic Saline post lipo-abdominoplasty 20cc of 10% Hypertonic Saline
Receives: Drug: Hypertonic Saline 10%
Group C Control GroupPlacebo comparatorLipo-Abdominoplasty
Receives: Drug: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 weeks

  2. number of abdominoplasty patients having seroma after intraoperative hypertonic saline irrigation

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

    Measured: 8 weeks

Secondary outcomes (6)
  1. days needed to remove the drain post abdominoplasty after intraoperative triamcinolone irrigation

    drains are removed when the amount in 24 hours is less than 50 cc

    Measured: up to 15 days

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

    drains are removed when the amount in 24 hours is less than 50 cc

    Measured: Up to 15 days

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

    amount is aspirated by a syringe and documented each session of aspiration

    Measured: 8 weeks

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

    amount is aspirated by a syringe and documented each session of aspiration

    Measured: 8 weeks

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

    drains are monitored and emptied every 12 hours and the amount is documented

    Measured: up to 15 days

  6. total drain output, measured in cc, post abdominoplasty after intraoperative hypertonic saline irrigation

    drains are monitored and emptied every 12 hours and the amount is documented

    Measured: up to 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start1 Nov 2023
  3. Primary completion1 Jul 2025
  4. Study completion1 Aug 2025

Resources

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07733921
Sponsor's protocol ID
MD-468-2023
Status last verified
Jul 2026
First submitted
19 Jul 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We dont have plans on sharing it at the time being yet if it is needed for authentication of data we will are gladly willing to share it

Publications

  • 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.

    PubMed 38720102
  • 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.

    PubMed 31055707
  • 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.

    PubMed 36502314
  • 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.

    PubMed 28350654
  • 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.

    PubMed 26179672
  • 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.

    PubMed 30259166
  • 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.

    PubMed 33565825
  • 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.

    PubMed 37014057
  • 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.

    PubMed 39015354
  • 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.

    PubMed 28158391
  • 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.

    PubMed 38585023
  • 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.

    PubMed 34080041
  • 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.

    PubMed 19331937

Questions about this trial

What is this clinical trial studying?

A study testing Irrigation of Triamcinolone and Hypertonic Saline 10% in people with Seroma Formation, run by Cairo University at 1 site in Egypt.

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 4 inclusion and 7 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 29 Jul 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?

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?

number of abdominoplasty patients having seroma after intraoperative Triamcinolone irrigation (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT07733921, which also lists 13 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 Jul 2026.

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