Surgical Wound DehiscencePhase 2NCT01679678
A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen
A Phase 2 study testing PolyHeal 2 and Polyheal in people with Surgical Wound Dehiscence, run by MediWound Ltd at 4 sites in Israel.
Trial summary
This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Wound Dehiscence
- What is being tested?
- PolyHeal 2 and Polyheal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesIsrael
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent)
- Subjects who are able to read, understand, and sign the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required.
Who cannot join
- Presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
- Wounds with exposed bones, tendons or ligaments
- Wounds with exposed orthopedic implants
- Wounds with exposed breast prostheses
- Uncontrolled diabetes with HbA1c >11%
- Subjects with BMI greater than 35kg/m2
- Woman who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
- Participation in another clinical drug/device trial within 30 days prior to the Screening visit or during this study
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Western Galilee Hospital
Nahariya
Souraski Medical Center
Tel Aviv
About this study
Official title: A Double Blind, Randomized, Controlled Study, Performed in Subjects With Post Traumatic-post Surgical, Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of Polyheal-2 vs PolyHeal in Once Daily Regimen
This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.
Read the detailed description
Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks.
Continuation of study device for additional period is based on wound healing progression and under investigator's discretion.
Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.
- Conditions
- Surgical Wound Dehiscence
- Being tested
- PolyHeal 2, Polyheal
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyHeal 2Device
Also called PolyHeal, PolyHeal is a sterile medical device
PolyHeal is a sterile medical device
PolyhealDevice
Also called PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM
PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
| Study group | Role | What they receive |
|---|---|---|
| PolyHeal 2 | Experimental | Negatively charged 5-micron polystyrene microspheres in Water For Injection Receives: Device: PolyHeal 2 |
| PolyHeal | Active comparator | Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM) Receives: Device: Polyheal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Business considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound DehiscenceStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Berezovsky, MD, Principal investigator, Head of Department of Plastic and reconstructive surgeryEyal Gur, MD, Principal investigator, Head of Plastic and Reconstructive Surgery Department, Souraski Medical CenterLeonid Kogan, MD, Principal investigator, Head of Plastic Surgery Department Western Galilee HospitalYehuda Ulman, Proffesor, Principal investigator, Head of Plastic surgery department ,Rambam Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679678
- Sponsor's protocol ID
- MWPH-2012-08-01
- Status last verified
- Mar 2016
- First submitted
- 20 Aug 2012
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Controlled Study, Performed in Subjects With Post Traumatic-post Surgical, Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of Polyheal-2 vs PolyHeal in Once Daily Regimen
- ClinicalTrials.gov ID
- NCT01679678
- Acronym / sponsor ID
- MWPH-2012-08-01
- Conditions
- Surgical Wound Dehiscence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business considerations
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Sep 2012 (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 is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.
Detailed description
Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks.
Continuation of study device for additional period is based on wound healing progression and under investigator's discretion.
Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PolyHeal 2 | Experimental | Device: PolyHeal 2Negatively charged 5-micron polystyrene microspheres in Water For Injection |
| PolyHeal | Active comparator | Device: PolyhealNegatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent)
- Subjects who are able to read, understand, and sign the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required.
Key exclusion criteria (8 listed)
- Presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
- Wounds with exposed bones, tendons or ligaments
- Wounds with exposed orthopedic implants
- Wounds with exposed breast prostheses
- Uncontrolled diabetes with HbA1c >11%
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 |
|---|---|---|
| PolyHeal 2Also: PolyHeal, PolyHeal is a sterile medical devicePolyHeal is a sterile medical device | Device | PolyHeal 2 |
| PolyhealAlso: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEMPolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in | Device | PolyHeal |
Primary outcome
Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Business considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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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.
Alex Berezovsky, MD principal investigator
Head of Department of Plastic and reconstructive surgery
Eyal Gur, MD principal investigator
Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center
Leonid Kogan, MD principal investigator
Head of Plastic Surgery Department Western Galilee Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PolyHeal 2 and Polyheal in people with Surgical Wound Dehiscence, run by MediWound Ltd at 4 sites in Israel.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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 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.
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 was stopped early (reason given: Business considerations). Results are not available in the source record.
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?
Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase) (time frame: 4 weeks). 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 30 Mar 2016.