Impact of Iron Stores on Wound Healing in Plastic Surgery
IRONPLAST
1 other identifier
observational
400
1 country
1
Brief Summary
In breast reduction surgery, delayed wound healing may increase surgical site infections, cutaneous necrosis and may be related to psychological harm.Some risk factors have been identified : smoking, diabetes, overweight. A normal healing involve cellular and biochemical reactions in which iron plays an important role such as cellular respiration, redox reactions and regulation of genes involved in the cell cycle. This trial will study the relationship between iron stores and postoperative wound healing after bilateral breast reduction surgery in patients without preoperative anaemia.The primary outcome of this trial is the comparison of wound healing at post operative day 15, between patients with and without iron deficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedAugust 19, 2020
February 1, 2020
5 months
February 17, 2020
August 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of good breast tissue healing on each breast
Good healing is defined as a score of 0, 1 or 2 on a 16 points-specifc scale. The scale evaluate proportion of disunity for periareolar vertical and horizontal incisions
15 days after surgery
Secondary Outcomes (5)
Evaluation of healing on the 16 points specific scale
15 days after surgery
Proportion of early complications
up to 15 days after surgery
Proportion of closed drainage orifices
15 days after surgery
Correlation between serum ferritin levels before surgery and score on the healing scale
15 days after surgery
Intra-class correlation coefficient for the healing scale
15 days after surgery
Eligibility Criteria
Cohort of woman who had a scheduled bilateral breast reduction surgery without anemia
You may qualify if:
- age \>18 years
- female
- scheduled bilateral breast reduction surgery
- biological exams with ferritin and transferrin saturation coefficient taken the day before surgery
- No anemia : haemoglobin \>=12g/dL (preoperative biological assessment )
- if genetic disease of haemoglobin, haemoglobin between 10 and 12g/dL and no Anaemia by iron deficiency
- absence of clinical inflammatory syndrome (no clinical signs of infection or no fever)
- non-opposition of the patient to participate
You may not qualify if:
- Anaemia by iron deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Louis hospital
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 19, 2020
Study Start
August 1, 2020
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
August 19, 2020
Record last verified: 2020-02