Dupuytren's ContracturePhase 2/3NCT00931567
Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing
A Phase 2/3 study testing Autologous platelets gel and Vaselitulle in people with Dupuytren's Contracture, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
This study is a clinical, multicentric, randomised open trial. The objective is to evaluate the efficiency, in terms of wound healing speed, of peroperative application of autologous platelets gel versus standardized wound dressing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Contracture
- What is being tested?
- Autologous platelets gel and Vaselitulle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Aug 2007to Feb 2010
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Patient with Dupuytren's disease with an indication of surgical treatment using the open palm technique.
- Agreement form signed
- patient affiliated to the national health system.
Who cannot join
- Patients allergic to one of the components of the dressings used in this study.
- Patients with insulin-requiring diabetes
- Patients sustaining anti-cancer treatment.
- Pregnant women.
- Patients included in another study.
- Patients who cannot come to the follow up visits.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Hôpital de la Timone
Marseille, Cedex 05, 13385
Centre Hospitalier Universitaire de Nice Hôpital de Cimiez
Nice, 06000
About this study
This study is a clinical, multicentric, randomised open trial. The objective is to evaluate the efficiency, in terms of wound healing speed, of peroperative application of autologous platelets gel versus standardized wound dressing. The wound Healing model used in this study is the " open palm " surgical treatment of Dupuytren's disease.
Dupuytren's disease is a fibroproliferative disease of the palmar and digital fascia of the hand that may lead to a fixed flexion contracture of the fingers.
Read more
The main indication for surgery is the loss of finger extension. In some cases of palmar Dupuytren's disease the surgical removal of diseased tissues may lead to a cutaneous loss of substance (" open palm technique "). This loss of substance is treated using vaseline dressing and the wound healing is obtained in 4 weeks.
Autologous platelets gel (Platelet Rich Fibrin) is obtained from the patient's own blood. Some recent studies have shown that it speeds up the wound healing and enhances the quality of the scar.
PRF belongs to a new generation of autologous platelet gel that are easily obtained after centrifugation of patient's own blood.
The Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor (VEGF).
The study will be running on 60 days, starting from the operation day. The wound healing evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.
The inclusion criteria are : age over 18, Dupuytren's disease with an indication of surgical treatment using the open palm technique, patients having signed the agreement form.
80 patients will be included in the study and divided into 2 groups . The first group of patients will receive PRF and the other group will receive vaseline dressings.
The speed and the quality of wound healing will be compared.We will also compare the number of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain during the dressings' change and the bleeding of the palmar wound.
For the wound healing speed , a difference of 7 days between the two groups will be considered as statistically significant.
Statistical analysis will be achieved using Chi2 test and Logrank test.
Read the detailed description
Main evaluation criteria :
Time duration between the operation and the complete wound healing. The wound healing is considered complete when the skin is closed and when the patient do not need to have dressings. A picture of the wound at the end of the wound healing process is taken for each patient.
Secondary criteria of evaluation :
At day 1, day7, day 14, day 21 and day 28 two data will be collected :
- The pain during the dressings' change using a visual scale going from 0 (no pain) to 10 (very painful).
- The bleeding (and "exudate") of the wound which can be absent, low, moderate or abundant.
The investigators will collect all the side effects described by the patients for each wound healing technique.
- Conditions
- Dupuytren's Contracture
- Being tested
- Autologous platelets gel, Vaselitulle
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelets gelBiological
Application of autologous platelets gel (Platelet Rich Fibrin) after the " open palm " surgical treatment of Dupuytren's disease.
VaselitulleDevice
application of standardized wound dressing after the " open palm " surgical treatment of Dupuytren's disease.
| Study group | Role | What they receive |
|---|---|---|
| Vaselitulle | Active comparator | after surgery, the loss of substance is treated using vaseline dressing Receives: Device: Vaselitulle |
| Autologous platelets gel | Experimental | after surgery, the loss of substance is treated with Autologous platelets gel Receives: Biological: Autologous platelets gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time duration between the operation and the complete wound healing.
Measured: 18 months
Secondary outcomes (1)
-The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startAug 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren's ContractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931567
- Sponsor's protocol ID
- 01-APR-07
- Status last verified
- Mar 2012
- First submitted
- 30 Jun 2009
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chignon-Sicard B, Georgiou CA, Fontas E, David S, Dumas P, Ihrai T, Lebreton E. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial. Plast Reconstr Surg. 2012 Dec;130(6):819e-829e. doi: 10.1097/PRS.0b013e31826d1711.
PubMed 23190833
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing
- ClinicalTrials.gov ID
- NCT00931567
- Acronym / sponsor ID
- 01-APR-07
- Conditions
- Dupuytren's Contracture
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- University Hospital, Marseille
- Study start
- Aug 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Jul 2009 (estimated)
- 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.
This study is a clinical, multicentric, randomised open trial. The objective is to evaluate the efficiency, in terms of wound healing speed, of peroperative application of autologous platelets gel versus standardized wound dressing. The wound Healing model used in this study is the " open palm " surgical treatment of Dupuytren's disease.
Dupuytren's disease is a fibroproliferative disease of the palmar and digital fascia of the hand that may lead to a fixed flexion contracture of the fingers.
The main indication for surgery is the loss of finger extension. In some cases of palmar Dupuytren's disease the surgical removal of diseased tissues may lead to a cutaneous loss of substance (" open palm technique "). This loss of substance is treated using vaseline dressing and the wound healing is obtained in 4 weeks.
Autologous platelets gel (Platelet Rich Fibrin) is obtained from the patient's own blood. Some recent studies have shown that it speeds up the wound healing and enhances the quality of the scar.
PRF belongs to a new generation of autologous platelet gel that are easily obtained after centrifugation of patient's own blood.
The Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor (VEGF).
The study will be running on 60 days, starting from the operation day. The wound healing evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.
The inclusion criteria are : age over 18, Dupuytren's disease with an indication of surgical treatment using the open palm technique, patients having signed the agreement form.
80 patients will be included in the study and divided into 2 groups . The first group of patients will receive PRF and the other group will receive vaseline dressings.
The speed and the quality of wound healing will be compared.We will also compare the number of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain during the dressings' change and the bleeding of the palmar wound.
For the wound healing speed , a difference of 7 days between the two groups will be considered as statistically significant.
Statistical analysis will be achieved using Chi2 test and Logrank test.
Detailed description
Main evaluation criteria :
Time duration between the operation and the complete wound healing. The wound healing is considered complete when the skin is closed and when the patient do not need to have dressings. A picture of the wound at the end of the wound healing process is taken for each patient.
Secondary criteria of evaluation :
At day 1, day7, day 14, day 21 and day 28 two data will be collected :
- The pain during the dressings' change using a visual scale going from 0 (no pain) to 10 (very painful).
- The bleeding (and "exudate") of the wound which can be absent, low, moderate or abundant.
The investigators will collect all the side effects described by the patients for each wound healing technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaselitulle | Active comparator | Device: Vaselitulleafter surgery, the loss of substance is treated using vaseline dressing |
| Autologous platelets gel | Experimental | Biological: Autologous platelets gelafter surgery, the loss of substance is treated with Autologous platelets gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Patient with Dupuytren's disease with an indication of surgical treatment using the open palm technique.
- Agreement form signed
- patient affiliated to the national health system.
Key exclusion criteria (6 listed)
- Patients allergic to one of the components of the dressings used in this study.
- Patients with insulin-requiring diabetes
- Patients sustaining anti-cancer treatment.
- Pregnant women.
- Patients included in another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous platelets gelApplication of autologous platelets gel (Platelet Rich Fibrin) after the " open palm " surgical treatment of Dupuytren's disease. | Biological | Autologous platelets gel |
| Vaselitulleapplication of standardized wound dressing after the " open palm " surgical treatment of Dupuytren's disease. | Device | Vaselitulle |
Primary outcome
Time duration between the operation and the complete wound healing.
Time frame: 18 months
1 secondary outcome
-The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Derived from this study: PubMed 23190833Chignon-Sicard B, Georgiou CA, Fontas E, David S, Dumas P, Ihrai T, Lebreton E. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial. Plast Reconstr Surg. 2012 Dec;130(6):819e-829e. doi: 10.1097/PRS.0b013e31826d1711.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous platelets gel and Vaselitulle in people with Dupuytren's Contracture, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time duration between the operation and the complete wound healing. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00931567, which also lists 1 linked publication.
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 20 Mar 2012.