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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.
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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidermal Graft | Experimental | The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts as per existing normal clinical practice. |
|
| Split Thickness Skin Graft | Experimental | Split thickness skin graft will be harvested using air dermatome as per normal clinical practise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidermal grafting | Device | The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Wounds With Complete Healing | Number of wounds with complete healing at 6 weeks | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Wound Healing | Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toby Richards, MD FRCS | University College, London | Principal Investigator |
| Afshin Mosahebi, MBBS FRCS PhD MBA | Royal Free Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Free Hampstead NHS Trust Hospital | London | NW3 2QG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32532631 | Derived | 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. | |
| 27185033 |
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A total of 61 patients were screened for eligibility; 44 of them fulfilled the inclusion criteria and were randomized to the two study groups (EG and SSG) between October 2015 and September 2017. Participants were recruited at the Royal Free London NHS Foundation Trust Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidermal Graft | Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts. |
| FG001 | Split Thickness Skin Graft | Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidermal Graft | Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts. |
| BG001 | Split Thickness Skin Graft | Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Wounds With Complete Healing | Number of wounds with complete healing at 6 weeks | Posted | Number | number of wounds | 6 weeks and 3 months | Number of wounds | Number of wounds |
|
3 months
The incidence of serious adverse events (SAEs) include mortality of any cause within the three months duration from the time of initial therapy, and the incidence of device-related adverse events (DAEs) and wound-related adverse events (WAEs) occurring within the study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidermal Graft | Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EPIGRAAFT Trial team | UCL | 020 7679 2000 | epigraaft@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2016 | Jul 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014456 | Ulcer |
| D012883 | Skin Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Split thickness skin grafting | Procedure | Split thickness skin grafting will be performed as per normal clinical practice. |
|
| 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. | 6 weeks and 3 months |
| Adverse Events | Number of participants with of adverse events | 3 months |
| Derived |
| Kanapathy 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Wound size (cm^2) | Mean | Standard Deviation | cm^2 |
|
| Duration of wound (week) | Mean | Standard Deviation | week |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Number of wounds |
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| Primary | Mean Time for Donor Site Healing | Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings | Posted | Mean | 95% Confidence Interval | days | 3 months |
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| Secondary | Time for Wound Healing | Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings | Posted | Mean | 95% Confidence Interval | week | 3 months |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | unit of a scale | 6 weeks and 3 months |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks and 3 months |
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| Secondary | Adverse Events | Number of participants with of adverse events | Posted | Number | participants | 3 months |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Split Thickness Skin Graft | Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice. | 0 | 22 | 0 | 22 | 0 | 22 |
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At 3 months |
| Superiority |