Impact of Iron Stores on Wound Healing in Plastic Surgery

Iron-deficiency Clinical Trial

— IRONPLAST  

Official title:

Impact of Iron Stores on Wound Healing in Plastic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04276168
• Other study ID #: APHP190575
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: February 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Aristide Ntahe
• Phone: 0142495191
• Email: aristide.ntahe[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healing Wound
• Iron-deficiency
• Surgical Wound
• Wounds and Injuries

Locations

Country	Name	City	State
France	Saint Louis hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of healing on the 16 points specific scale		15 days after surgery
Secondary	Proportion of early complications		up to 15 days after surgery
Secondary	Proportion of closed drainage orifices		15 days after surgery
Secondary	Correlation between serum ferritin levels before surgery and score on the healing scale		15 days after surgery
Secondary	Intra-class correlation coefficient for the healing scale		15 days after surgery