Healing Wound, Iron-deficiency, Surgical Wound
Conditions
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Anaemia by iron deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of good breast tissue healing on each breast | 15 days after surgery | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
Primary ContactAristide Ntahe
Outcome results
None listed