Impact of Iron Stores on Wound Healing in Plastic Surgery

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

• Registration Number: NCT04276168
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of early complications	up to 15 days after surgery
Evaluation of healing on the 16 points specific scale	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

Trial Locations

Locations (1)

Saint Louis hospital; 🇫🇷 Paris, France