Wound HealPhase 3Split WoundNCT03668665
Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"
A Phase 3 study testing Ready Medical Post Treatment and Conventionell Treatment in people with Wound Heal, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Heal
- What is being tested?
- Ready Medical Post Treatment and Conventionell Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2018to Oct 2020
- Phase
- Phase 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-90 years
- Split skin removal at the thigh must be planned for the patients
- Adult patients who are mentally and physically able to understand the importance and scope of the study and to follow up the study staff
- Written informed consent before participating in the study
Who cannot join
- Patients suffering from a systemic disease (e.g. diabetes mellitus, anticoagulant therapy,...)
- Patients taking immunosuppressive drugs that may affect wound healing
- Patients suffering from skin diseases
- Pregnant and/or lactating women. Women of childbearing age should protect themselves from potential pregnancy by adequate contraception while participating in studies.
- Participation in a study may, at the investigator's discretion, present an unacceptable risk due to pre- or concomitant disease or the patient's general underlying condition.
- Underage, or older than 90 years
Show all 14Show fewer
- Life span is less than six months
- There is a current or past medically relevant disease or treatment that could influence the evaluation of the study
- The patient has received a study medication within the last 30 days as part of another study
- Simultaneous participation in another clinical intervention study
- Expected lack of compliance
- Alcohol or drug abuse
- The patient is accommodated in an institution by official or court order
- Patients in a dependent relationship or employment relationship with the sponsor, investigator, or alternate investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of oral and maxillofacial surgery, University Hospital RWTH Aachen Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.
Read the detailed description
In oral and maxillofacial surgery, split skin is regularly removed to cover secondary defects. These defects occur, for example, in tumor patients after the removal of microsurgical radialis or fibular grafts for defect coverage or reconstruction, since the skin cannot be primarily closed there.
Split skin is defined as a free skin graft made of epidermis and the upper parts of the dermis. The average thickness of the grafts is 0.2-0.8 mm. The thickness of the split skin determines the pigmentation structure and the quality of the graft. The thinner the split skin, the better the healing tendency and the less scar remains at the donor site. However, a disadvantage of thin split skin grafts is the stronger secondary shrinkage in the recipient region. Moderately thick grafts are hardly subject to scar shrinkage, but occasionally leave hypertrophic scars or keloids at the donor site. Split skin grafts with a thickness of 0.6-0.8 mm provide the best esthetic results, but have a poorer healing rate.
The split skin can be removed with a dermatome. The ventrolateral proximal thighs and the inside and outside of the upper arms are particularly suitable as donor regions.
In oral and maxillofacial surgery, a 0.4 mm thick split skin is usually removed from the ventrolateral thigh to cover the defect in the forearm or lower leg.
The requirement at the split skin removal site is rapid healing with complete re-epithelialization. To achieve this, wound management is currently left to the clinic itself, as there is no evidence-based standard care. The technical literature only recommends moist wound management and rare dressing changes.
A new product that promises faster healing and reduced scarring of these wounds is Ready Medical Post Treatment. This is an established preparation consisting of hyaluronic acid, perfluorodecalin and Physalis angulata extract. Studies have shown that both hyaluronic acid and perfluorodecalin can significantly improve the epithelialisation rate of wounds. The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.
- Conditions
- Wound Heal
- Being tested
- Ready Medical Post Treatment, Conventionell Treatment
- Keywords
- Split Skin Removal, Hyaloronic acid, Split Wound Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready Medical Post TreatmentDrug
Also called Hyaluronic acid combined with perfluorodecalin and Physalis angulata extract
Treatment of half of the wound with the product "ready medical post treatment" in addition to conventional treatment with moist dressings (Mepilex and Fixomull); on the 1st, 4th and 7th day after surgery, the product is applied to the wound and the dressing is changed
Conventionell TreatmentDevice
Also called Wound treatment with moist dressings
Treatment of half of the wound with conventional moist dressings (Mepilex and Fixomull); a dressing change only takes place on the 7th day postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Conventionell Treatment | Active comparator | After split skin removal, the wound is divided into 2 parts (=2 arms):
1st half: conventional treatment with moist dressings (mepilex and fixomull) Receives: Device: Conventionell Treatment |
| Treatment with Ready Medical Post Treatment | Experimental | After split skin removal, the wound is divided into 2 parts (=2 arms):
2nd half: conventional treatment with moist dressings (mepilex and fixomull) and additional treatment with ready medical post treatment Receives: Drug: Ready Medical Post Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Ready Medical Post Treatment on wound healing after split skin removal
Evaluation of the process control of wound healing (three-dimensional scans of the thigh) by surgeons and patients using questionnaire (wound assessment by "Patient and Observer Scar Assessment Scale")
Patient and Observer Scar Assessment Scale: Vancouver Scar Scale, surface area; patient assessments of pain, itching, color, stiffness, thickness, relief (Score from 5 (best) to 50 (worse)
Measured: 6.5 month
Effect of Ready Medical Post Treatment on wound healing after split skin removal
Evaluation of the process control of wound healing (three-dimensional scans of the thigh) by surgeons and patients using questionnaire (wound assessment by "Manchester Scar Scale")
Manchester Scar Scale: VAS (Visual Analog Scale) plus scar color, skin texture, relationship to surrounding skin, texture, margins, size, multiplicity (Score from 5 (best) to 18 (worse)
Measured: 6.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: no approval by CA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The wound is divided into two halves (top and bottom). During the in-patient stay, half of the split skin removal sites are treated with Ready Medical Post Treatment on the 1st, 4th and 7th postoperative days in addition to conventional treatment with moist dressings (Mepilex and Fixomull). The other half of the wound should only be treated with conventional dressings as a control. Half of those treated with Ready Medical Post Treatment receive a new dressing after each application.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668665
- Sponsor's protocol ID
- 18-068
- Acronym
- Split Wound
- Status last verified
- Mar 2019
- First submitted
- 5 Sep 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"
- ClinicalTrials.gov ID
- NCT03668665
- Acronym / sponsor ID
- Split Wound / 18-068
- Conditions
- Wound Heal
- Keywords
- Split Skin Removal, Hyaloronic acid, Split Wound Design
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no approval by CA
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 12 Sep 2018 (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.
The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.
Detailed description
In oral and maxillofacial surgery, split skin is regularly removed to cover secondary defects. These defects occur, for example, in tumor patients after the removal of microsurgical radialis or fibular grafts for defect coverage or reconstruction, since the skin cannot be primarily closed there.
Split skin is defined as a free skin graft made of epidermis and the upper parts of the dermis. The average thickness of the grafts is 0.2-0.8 mm. The thickness of the split skin determines the pigmentation structure and the quality of the graft. The thinner the split skin, the better the healing tendency and the less scar remains at the donor site. However, a disadvantage of thin split skin grafts is the stronger secondary shrinkage in the recipient region. Moderately thick grafts are hardly subject to scar shrinkage, but occasionally leave hypertrophic scars or keloids at the donor site. Split skin grafts with a thickness of 0.6-0.8 mm provide the best esthetic results, but have a poorer healing rate.
The split skin can be removed with a dermatome. The ventrolateral proximal thighs and the inside and outside of the upper arms are particularly suitable as donor regions.
In oral and maxillofacial surgery, a 0.4 mm thick split skin is usually removed from the ventrolateral thigh to cover the defect in the forearm or lower leg.
The requirement at the split skin removal site is rapid healing with complete re-epithelialization. To achieve this, wound management is currently left to the clinic itself, as there is no evidence-based standard care. The technical literature only recommends moist wound management and rare dressing changes.
A new product that promises faster healing and reduced scarring of these wounds is Ready Medical Post Treatment. This is an established preparation consisting of hyaluronic acid, perfluorodecalin and Physalis angulata extract. Studies have shown that both hyaluronic acid and perfluorodecalin can significantly improve the epithelialisation rate of wounds. The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The wound is divided into two halves (top and bottom). During the in-patient stay, half of the split skin removal sites are treated with Ready Medical Post Treatment on the 1st, 4th and 7th postoperative days in addition to conventional treatment with moist dressings (Mepilex and Fixomull). The other half of the wound should only be treated with conventional dressings as a control. Half of those treated with Ready Medical Post Treatment receive a new dressing after each application.
| Arm | Type | Receives |
|---|---|---|
| Conventionell Treatment | Active comparator | Device: Conventionell TreatmentAfter split skin removal, the wound is divided into 2 parts (=2 arms): 1st half: conventional treatment with moist dressings (mepilex and fixomull) |
| Treatment with Ready Medical Post Treatment | Experimental | Drug: Ready Medical Post TreatmentAfter split skin removal, the wound is divided into 2 parts (=2 arms): 2nd half: conventional treatment with moist dressings (mepilex and fixomull) and additional treatment with ready medical post treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-90 years
- Split skin removal at the thigh must be planned for the patients
- Adult patients who are mentally and physically able to understand the importance and scope of the study and to follow up the study staff
- Written informed consent before participating in the study
Key exclusion criteria (14 listed)
- Patients suffering from a systemic disease (e.g. diabetes mellitus, anticoagulant therapy,...)
- Patients taking immunosuppressive drugs that may affect wound healing
- Patients suffering from skin diseases
- Pregnant and/or lactating women. Women of childbearing age should protect themselves from potential pregnancy by adequate contraception while participating in studies.
- Participation in a study may, at the investigator's discretion, present an unacceptable risk due to pre- or concomitant disease or the patient's general underlying condition.
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 |
|---|---|---|
| Ready Medical Post TreatmentAlso: Hyaluronic acid combined with perfluorodecalin and Physalis angulata extractTreatment of half of the wound with the product "ready medical post treatment" in addition to conventional treatment with moist dressings (Mepilex and Fixomull); on the 1st, 4th and 7th day after surgery, the product is applied to the wound and the dressing is changed | Drug | Treatment with Ready Medical Post Treatment |
| Conventionell TreatmentAlso: Wound treatment with moist dressingsTreatment of half of the wound with conventional moist dressings (Mepilex and Fixomull); a dressing change only takes place on the 7th day postoperatively | Device | Conventionell Treatment |
Primary outcome
Effect of Ready Medical Post Treatment on wound healing after split skin removal
Time frame: 6.5 month
Evaluation of the process control of wound healing (three-dimensional scans of the thigh) by surgeons and patients using questionnaire (wound assessment by "Patient and Observer Scar Assessment Scale") Patient and Observer Scar Assessment Scale: Vancouver Scar Scale, surface area; patient assessments of pain, itching, color, stiffness, thickness, relief (Score from 5 (best) to 50 (worse)
Effect of Ready Medical Post Treatment on wound healing after split skin removal
Time frame: 6.5 month
Evaluation of the process control of wound healing (three-dimensional scans of the thigh) by surgeons and patients using questionnaire (wound assessment by "Manchester Scar Scale") Manchester Scar Scale: VAS (Visual Analog Scale) plus scar color, skin texture, relationship to surrounding skin, texture, margins, size, multiplicity (Score from 5 (best) to 18 (worse)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ready Medical Post Treatment and Conventionell Treatment in people with Wound Heal, run by RWTH Aachen University at 1 site in Germany.
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 14 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: withdrawn, as of the sponsor's last update on 14 Mar 2019. 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 Germany. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of Ready Medical Post Treatment on wound healing after split skin removal (time frame: 6.5 month). The study lists 2 primary outcomes in all. 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 14 Mar 2019.