UlcerEPIGRAAFTNCT02535481
Epidermal Grafting in Wound Healing
A study testing Epidermal grafting and Split thickness skin grafting in people with Ulcer and Skin Ulcer, run by University College, London at 1 site in United Kingdom.
Trial summary
Split thickness skin grafting is the normal standard of care for wound closure. However, this is an invasive procedure and associated with pain also there can be additional donor site morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical practise. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcer, Skin Ulcer, Wounds and Injuries
- What is being tested?
- Epidermal grafting and Split thickness skin grafting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18-90
- Wound measuring more than 1cm x 1cm and lesser than 5cm x 5cm (1% TBSA)
- Wound with clean, healthy granulating bed, with minimal adherent slough
- Patient understands and is willing to participate and can comply with weekly visits and follow-up regime
Who cannot join
- Wound with active infection
- Wound at plantar of the foot
- Patients unsuitable for Split Skin Grafting
- Previous history of excessive bleeding associated with surgical biopsies or trauma
- Allergies to tegaderm (and other dressings used in the study)
- Known uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%.
- Presence of one or more medical conditions, including renal, hepatic, hematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study
- Patient not fit for surgery (ASA classification > 4)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Free Hampstead NHS Trust Hospital
London, NW3 2QG
About this study
Official title: A Multi-centre Randomised Controlled Trial to Compare Epidermal Grafting With Split Skin Grafting for Wound Healing
Split thickness skin grafting is the normal standard of care for wound closure. However, this is an invasive procedure and associated with pain also there can be additional donor site morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that 'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This potentially results in less pain and reduced donor site morbidity but only delivers several cell layers to the wound so may be less effective at healing a wound. It is not known if EG is an effective alternative to SSG.
Further the mechanism to achieve wound healing may be different. EG promotes wound healing by expressing growth factors that accelerates wound healing and encourages keratinocyte migration. Whereas SSG is a transplant of several skin layers that integrated to the existing wound bed as a formal skin covering.
The investigators wish to compare these two clinical practises; epidermal grafting and split thickness skin grafting in wound healing. Further to undertake a translational study to investigate the mechanism by which each technique achieves wound healing.
Read the detailed description
This study evaluates the efficacy of EG, as an alternative to current wound management therapy, SSG. In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site. Moreover, complete wound epithelialisation was achieved while maintaining patient independence. Therefore, this device has the potential to save healthcare resources, by eliminating the need for theatre space and a hospital bed, and result in better Patient Reported Outcomes Measures.
- Conditions
- Ulcer, Skin Ulcer, Wounds and Injuries
- Being tested
- Epidermal grafting, Split thickness skin grafting
- Keywords
- epidermal graft, suction blister, blister graft, suction graft, Epidermis/su, tr [Surgery, Transplantation]
- Medical subject headings
- Ulcer, Skin Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidermal graftingDevice
Also called CelluTome
The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts.
Split thickness skin graftingProcedure or surgery
Split thickness skin grafting will be performed as per normal clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Epidermal Graft | Experimental | The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts as per existing normal clinical practice. Receives: Device: Epidermal grafting |
| Split Thickness Skin Graft | Experimental | Split thickness skin graft will be harvested using air dermatome as per normal clinical practise. Receives: Procedure: Split thickness skin grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Wounds With Complete Healing
Number of wounds with complete healing at 6 weeks
Measured: 6 weeks and 3 months
Mean Time for Donor Site Healing
Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings
Measured: 3 months
Secondary outcomes (4)
Time for Wound Healing
Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings
Measured: 3 months
Donor Site Morbidity
The donor site morbidity was measured using the Vancouver Scar Scale (VSS). Total score scale ranges from 0 to 13. Lower score is more desirable as it represents a scar resembling normal surrounding skin. The scale assesses 4 categories: vascularity, height, pliability, and pigmentation. Total score is obtained by the sum of the categories.
Measured: 6 weeks and 3 months
Patient Reported Outcome Measure (PROM)
Patient reported outcome measure was assessed using a validated skin graft satisfaction questionnaire.The skin graft satisfaction questionnaire has a scale ranging from 1 to 7, with 1 representing very unsatisfied while 7 represents very satisfied. Hence, higher score represent higher satisfaction.
Measured: 6 weeks and 3 months
Adverse Events
Number of participants with of adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UlcerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toby Richards, MD FRCS, Principal investigator, University College, LondonAfshin Mosahebi, MBBS FRCS PhD MBA, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535481
- Sponsor's protocol ID
- 15/0079
- Acronym
- EPIGRAAFT
- Status last verified
- Jul 2020
- First submitted
- 11 Aug 2015
- Last updated
- 10 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kanapathy M, Bystrzonowski N, Hachach-Haram N, Twyman L, Becker DL, Richards T, Mosahebi A. Lower donor site morbidity and higher patient satisfaction with epidermal grafting in comparison to split thickness skin grafting: A randomized controlled trial (EPIGRAAFT Trial). J Plast Reconstr Aesthet Surg. 2020 Aug;73(8):1556-1564. doi: 10.1016/j.bjps.2020.03.006. Epub 2020 Mar 16.
PubMed 32532631Kanapathy M, Hachach-Haram N, Bystrzonowski N, Harding K, Mosahebi A, Richards T. Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial. Trials. 2016 May 17;17(1):245. doi: 10.1186/s13063-016-1352-y.
PubMed 27185033
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomised Controlled Trial to Compare Epidermal Grafting With Split Skin Grafting for Wound Healing
- ClinicalTrials.gov ID
- NCT02535481
- Acronym / sponsor ID
- EPIGRAAFT / 15/0079
- Conditions
- Ulcer, Skin Ulcer, Wounds and Injuries
- Keywords
- epidermal graft, suction blister, blister graft, suction graft, Epidermis/su, tr [Surgery, Transplantation]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Posted 10 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Split thickness skin grafting is the normal standard of care for wound closure. However, this is an invasive procedure and associated with pain also there can be additional donor site morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that 'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This potentially results in less pain and reduced donor site morbidity but only delivers several cell layers to the wound so may be less effective at healing a wound. It is not known if EG is an effective alternative to SSG.
Further the mechanism to achieve wound healing may be different. EG promotes wound healing by expressing growth factors that accelerates wound healing and encourages keratinocyte migration. Whereas SSG is a transplant of several skin layers that integrated to the existing wound bed as a formal skin covering.
The investigators wish to compare these two clinical practises; epidermal grafting and split thickness skin grafting in wound healing. Further to undertake a translational study to investigate the mechanism by which each technique achieves wound healing.
Detailed description
This study evaluates the efficacy of EG, as an alternative to current wound management therapy, SSG. In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site. Moreover, complete wound epithelialisation was achieved while maintaining patient independence. Therefore, this device has the potential to save healthcare resources, by eliminating the need for theatre space and a hospital bed, and result in better Patient Reported Outcomes Measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidermal Graft | Experimental | Device: Epidermal graftingThe Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts as per existing normal clinical practice. |
| Split Thickness Skin Graft | Experimental | Procedure: Split thickness skin graftingSplit thickness skin graft will be harvested using air dermatome as per normal clinical practise. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Age 18-90
- Wound measuring more than 1cm x 1cm and lesser than 5cm x 5cm (1% TBSA)
- Wound with clean, healthy granulating bed, with minimal adherent slough
- Patient understands and is willing to participate and can comply with weekly visits and follow-up regime
Key exclusion criteria (8 listed)
- Wound with active infection
- Wound at plantar of the foot
- Patients unsuitable for Split Skin Grafting
- Previous history of excessive bleeding associated with surgical biopsies or trauma
- Allergies to tegaderm (and other dressings used in the 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 |
|---|---|---|
| Epidermal graftingAlso: CelluTomeThe Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts. | Device | Epidermal Graft |
| Split thickness skin graftingSplit thickness skin grafting will be performed as per normal clinical practice. | Procedure or surgery | Split Thickness Skin Graft |
Primary outcome
Number of Wounds With Complete Healing
Time frame: 6 weeks and 3 months
Number of wounds with complete healing at 6 weeks
Mean Time for Donor Site Healing
Time frame: 3 months
Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings
4 secondary outcomes
Time for Wound Healing
Time frame: 3 months
Donor Site Morbidity
Time frame: 6 weeks and 3 months
Patient Reported Outcome Measure (PROM)
Time frame: 6 weeks and 3 months
Adverse Events
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32532631Kanapathy M, Bystrzonowski N, Hachach-Haram N, Twyman L, Becker DL, Richards T, Mosahebi A. Lower donor site morbidity and higher patient satisfaction with epidermal grafting in comparison to split thickness skin grafting: A randomized controlled trial (EPIGRAAFT Trial). J Plast Reconstr Aesthet Surg. 2020 Aug;73(8):1556-1564. doi: 10.1016/j.bjps.2020.03.006. Epub 2020 Mar 16.
- Derived from this study: PubMed 27185033Kanapathy M, Hachach-Haram N, Bystrzonowski N, Harding K, Mosahebi A, Richards T. Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial. Trials. 2016 May 17;17(1):245. doi: 10.1186/s13063-016-1352-y.
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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.
Toby Richards, MD FRCS principal investigator
University College, London
Afshin Mosahebi, MBBS FRCS PhD MBA principal investigator
Royal Free Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidermal grafting and Split thickness skin grafting in people with Ulcer and Skin Ulcer, run by University College, London at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 10 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Wounds With Complete Healing (time frame: 6 weeks and 3 months). 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?
On the ClinicalTrials.gov record for NCT02535481, which also lists 2 linked publications.
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 10 Aug 2020.