deltatrials
Completed PHASE2 INTERVENTIONAL NCT00227084

Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

Effect of Arista AH-Haemostatic Powder in Plastic Surgery. A Prospective, Consecutive Randomized Study in 30 Women Undergoing Reduction of Both Mamma

Sponsor: Medafor

Conditions Mammaplasty
Updated 5 times since 2017 Last updated: Aug 24, 2007 Started: Sep 30, 2005 Completion: Oct 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00227084, this PHASE2 trial focuses on Mammaplasty and remains completed. Sponsored by Medafor, it has been updated 5 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

During the operation,before the first incision a randomization envelope is opened. Always starts on the same side, with or without Arista according to the envelope. After surgery, vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had Arista.Patients scores postoperative pain with VAS score bilaterally. Three months postoperatively the patients are checked by a physician blinded for what side had Arista

During the operation,before the first incision a randomization envelope is opened. Always starts on the same side, with or without Arista according to the envelope. After surgery, vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had Arista.Patients scores postoperative pain with VAS score bilaterally.

Three months postoperatively the patients are checked by a physician blinded for what side had Arista

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Sep 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Medafor
  • Ullevaal University Hospital
  • University of Oslo
Data source: University of Oslo

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations