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

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.

Study Overview

• Status: Unknown
• Conditions: Iron-deficiency; Healing Wound; Surgical Wound

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Aristide Ntahe; Phone Number: 0142495191; Email: aristide.ntahe@aphp.fr

Study Locations

• France
  • Paris, France
    • Saint Louis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Cohort of woman who had a scheduled bilateral breast reduction surgery without anemia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: APHP190575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No