Dressing Wear Time After Breast Augmentation With Prosthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Time of Permanence of Dressing Following Breast Reconstruction

NCT01148823

Surgical Site Infection

COMPLETED NA

Dressing Wear Time After Reduction Mammaplasty

NCT01002391

Surgical Site Infection Skin Colonization

COMPLETED NA

Physical Activity and Sexuality After Reduction Mammaplasty

NCT01297621

Breast Hypertrophy

COMPLETED NA

Sexuality After Reduction Mammaplasty

NCT01020422

Sexual Function Depression

COMPLETED NA

Antibiotics After Breast Reduction:Clinical Trial With Randomization

NCT02569866

Surgical Site Infection

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.

The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.

CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Site Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Postoperative day 6

Dressing is removed on the sixth postoperative day

Group Type EXPERIMENTAL

augmentation mammaplasty

Intervention Type PROCEDURE

Dressing is removed on the 6th postoperative day

Postoperative day 1

Dressing is removed on the first postoperative day

Group Type EXPERIMENTAL

augmentation mammaplasty

Intervention Type PROCEDURE

Dressing is removed on the first postoperative day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

augmentation mammaplasty

Dressing is removed on the first postoperative day

Intervention Type PROCEDURE

augmentation mammaplasty

Dressing is removed on the 6th postoperative day

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* candidate to breast prosthesis implantation
* body mass index under 30Kg/m2

Exclusion Criteria

* pregnancy, delivery or breast feeding during the last 12 months
* body mass index over 30Kg/m2
* breast cancer history
* previous breast surgery
* hard smoking

Minimum Eligible Age

18 Months

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes