Healing WoundIRONPLASTNCT04276168
Impact of Iron Stores on Wound Healing in Plastic Surgery
An observational study of Healing Wound and Iron-deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healing Wound, Iron-deficiency, Surgical Wound
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2020to 15 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort of woman who had a scheduled bilateral breast reduction surgery without anemia
Who may be able to join
- 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
Who cannot join
- Anaemia by iron deficiency
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healing Wound, Iron-deficiency, Surgical Wound
- Medical subject headings
- Anemia, Iron-Deficiency, Surgical Wound
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days after surgery
Secondary outcomes (5)
Evaluation of healing on the 16 points specific scale
Measured: 15 days after surgery
Proportion of early complications
Measured: up to 15 days after surgery
Proportion of closed drainage orifices
Measured: 15 days after surgery
Correlation between serum ferritin levels before surgery and score on the healing scale
Measured: 15 days after surgery
Intra-class correlation coefficient for the healing scale
Measured: 15 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study startAug 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing WoundStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276168
- Sponsor's protocol ID
- APHP190575
- Acronym
- IRONPLAST
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Iron Stores on Wound Healing in Plastic Surgery
- ClinicalTrials.gov ID
- NCT04276168
- Acronym / sponsor ID
- IRONPLAST / APHP190575
- Conditions
- Healing Wound, Iron-deficiency, Surgical Wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of woman who had a scheduled bilateral breast reduction surgery without anemia
Key inclusion criteria (8 listed)
- 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 )
Key exclusion criteria (1 listed)
- Anaemia by iron deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of good breast tissue healing on each breast
Time frame: 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
5 secondary outcomes
Evaluation of healing on the 16 points specific scale
Time frame: 15 days after surgery
Proportion of early complications
Time frame: up to 15 days after surgery
Proportion of closed drainage orifices
Time frame: 15 days after surgery
Correlation between serum ferritin levels before surgery and score on the healing scale
Time frame: 15 days after surgery
Intra-class correlation coefficient for the healing scale
Time frame: 15 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healing Wound and Iron-deficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aristide Ntahe (0142495191, aristide.ntahe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of good breast tissue healing on each breast (time frame: 15 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.