Skin Ulcer, Ulcer, Wounds and Injuries
Conditions
Keywords
epidermal graft, suction blister, blister graft, suction graft, Epidermis/su, tr [Surgery, Transplantation]
Brief 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. 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 In a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site.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.
Interventions
DEVICEEpidermal grafting
The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts.
PROCEDURESplit thickness skin grafting
Split thickness skin grafting will be performed as per normal clinical practice.
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 2. Age 18-90 3. Wound measuring more than 1cm x 1cm and lesser than 5cm x 5cm (1% TBSA) 4. Wound with clean, healthy granulating bed, with minimal adherent slough 5. Patient understands and is willing to participate and can comply with weekly visits and follow-up regime
Exclusion criteria
1. Wound with active infection 2. Wound at plantar of the foot 3. Patients unsuitable for Split Skin Grafting 4. Previous history of excessive bleeding associated with surgical biopsies or trauma 5. Allergies to tegaderm (and other dressings used in the study) 6. Known uncontrolled Diabetes Mellitus, as measured by an HbA1c \> 10%. 7. 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 8. Patient not fit for surgery (ASA classification \> 4)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Wounds With Complete Healing | 6 weeks and 3 months | Number of wounds with complete healing at 6 weeks |
| Mean Time for Donor Site Healing | 3 months | Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for Wound Healing | 3 months | Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings |
| Donor Site Morbidity | 6 weeks and 3 months | 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. |
| Patient Reported Outcome Measure (PROM) | 6 weeks and 3 months | 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. |
| Adverse Events | 3 months | Number of participants with of adverse events |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Epidermal Graft Epidermal grafting: The Cellutome Epidermal Graft Harvesting System was used to harvest epidermal grafts. | 22 |
| Split Thickness Skin Graft Split thickness skin grafting: Split thickness skin grafting was performed as per normal clinical practice. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Epidermal Graft | Split Thickness Skin Graft | Total |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 19.9 | 59 years STANDARD_DEVIATION 18 | 58.7 years STANDARD_DEVIATION 19 |
| Duration of wound (week) | 48.9 week STANDARD_DEVIATION 75.4 | 7.86 week STANDARD_DEVIATION 16.1 | 28.4 week STANDARD_DEVIATION 58.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 30 Participants |
| Wound size (cm^2) | 12.7 cm^2 STANDARD_DEVIATION 9.9 | 16.5 cm^2 STANDARD_DEVIATION 11 | 14.6 cm^2 STANDARD_DEVIATION 10.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Mean Time for Donor Site Healing
Complete donor site healing was defined as 100% re-epithelialisation and not requiring further dressings
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Epidermal Graft | Mean Time for Donor Site Healing | 4.86 days |
| Split Thickness Skin Graft | Mean Time for Donor Site Healing | 21.32 days |
p-value: <0.0001Log Rank
Primary
Number of Wounds With Complete Healing
Number of wounds with complete healing at 6 weeks
Time frame: 6 weeks and 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epidermal Graft | Number of Wounds With Complete Healing | 6 weeks | 9 number of wounds |
| Epidermal Graft | Number of Wounds With Complete Healing | 3 months | 16 number of wounds |
| Split Thickness Skin Graft | Number of Wounds With Complete Healing | 6 weeks | 13 number of wounds |
| Split Thickness Skin Graft | Number of Wounds With Complete Healing | 3 months | 20 number of wounds |
p-value: 0.366Fisher Exact
p-value: 0.24Fisher Exact
Secondary
Adverse Events
Number of participants with of adverse events
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epidermal Graft | Adverse Events | 0 participants |
| Split Thickness Skin Graft | Adverse Events | 0 participants |
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.
Time frame: 6 weeks and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epidermal Graft | Donor Site Morbidity | 6 weeks | 0.14 unit of a scale | Standard Deviation 0.45 |
| Epidermal Graft | Donor Site Morbidity | 3 months | 0.09 unit of a scale | Standard Deviation 0.29 |
| Split Thickness Skin Graft | Donor Site Morbidity | 6 weeks | 3.73 unit of a scale | Standard Deviation 0.69 |
| Split Thickness Skin Graft | Donor Site Morbidity | 3 months | 2.91 unit of a scale | Standard Deviation 0.67 |
p-value: 0.001t-test, 2 sided
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.
Time frame: 6 weeks and 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Epidermal Graft | Patient Reported Outcome Measure (PROM) | 6 weeks | 7 score on a scale |
| Epidermal Graft | Patient Reported Outcome Measure (PROM) | 3 months | 7 score on a scale |
| Split Thickness Skin Graft | Patient Reported Outcome Measure (PROM) | 6 weeks | 6 score on a scale |
| Split Thickness Skin Graft | Patient Reported Outcome Measure (PROM) | 3 months | 6 score on a scale |
p-value: 0.001Wilcoxon (Mann-Whitney)
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Time for Wound Healing
Complete wound healing was defined as 100% re-epithelialisation and not requiring further dressings
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Epidermal Graft | Time for Wound Healing | 7.81 week |
| Split Thickness Skin Graft | Time for Wound Healing | 6.59 week |
p-value: 0.12Log Rank