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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00227084

Enrollment

Registered

2005-09-27

Start date

2005-09-30

Completion date

2006-10-31

Last updated

2007-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mammaplasty

Keywords

Mammary glands, hemostasis, Mammaplasty

Brief summary

To evaluate whether Arista AH which contains microporous polysaccharides used as a powder applied to the wound area during mammary surgery reduces the amount of bleeding and the duration of surgery. Both mammae are operated on in the same procedure, and one side without Arista serves as control side

Detailed description

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

Interventions

DRUGArista AH hemostasis powder

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* All women for mammary hypertrophy day surgery. No exclusions in this group.

Design outcomes

Primary

Measure	Time frame
duration of surgery	—
amount of bleeding on drain	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026