Impact of Iron Stores on Wound Healing in Plastic Surgery (IRONPLAST)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Iron-deficiency; Surgical Wound; Healing Wound

Study type: Observational

Funder types: Other

Identifiers

NCT04276168

APHP190575

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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