Impact of Iron Stores on Wound Healing in Plastic Surgery

NCT ID: NCT04276168

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-31

Study Completion Date

2020-12-15

Brief Summary

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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

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Conditions

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Healing Wound Iron-deficiency Surgical Wound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint Louis hospital

Paris, , France

Site Status

Countries

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France

Central Contacts

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Aristide Ntahe

Role: CONTACT

0142495191

Other Identifiers

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APHP190575

Identifier Type: -

Identifier Source: org_study_id

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