The aim of this study is to determine whether the alleged positive effects of ESG on acute surgical wounds as well as ESG effects on chronic wounds are attributable to this intervention.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary question:
Does Epidermal Skin Grafting affect the wound healing of patients with acute
and chronic wounds?
The outcome measure of wound healing contains two variables, duration to total
epithelialization and surface reduction per unit time. Both are measured using
digital photography and independent assessment (total epithelialization) and
digital photo analysis using the WHAT software (surface reduction).
In the acute wound group without SSG, we expect faster wound healing by the ESG
in the secondary healing donor site compared to the control group. In the acute
and chronic wound group that is indicated for SSG, the ESG group is expected to
display identical healing tendency as the SSG-receiving control group, but the
benefit is in pain perception, more limited or absent appearance of the scar
and an increased quality of life.
Secondary outcome
Secondary questions:
• What is the influence of ESG on the pain intensity of the donor and acceptor
site during the treatment process? Pain is measured with NRS (Numeric Rating
Scale) score
• What is the quality of the scar of the secondary healing wound with ESG
compared to the control group? The quality of the scar is measured with the
validated POSAS method, whereby both the patient and the doctor give an opinion
on, among other things, the redness, itching, swelling, lumpiness and pain of
scars.
• What is the influence on the patient's quality of life of both treatment
routes? Quality of life is measured with the validated scales EQ5D (generic)
and the Wound QoL (wound specific).
Background summary
Autologous skin grafting, such as a split skin graft (SSG), is a well-known
plastic surgical intervention to close wounds. While effective, this treatment
requires a trained surgeon to use anesthesia, an operating room, and makes a
wound at the donor site. Sometimes this intervention is not an option, e.g. in
the face, because of the poor aesthetic result. These drawbacks can be overcome
by using epidermal skin grafts, which can be harvested and transplanted at an
outpatient clinic, without anesthesia and with minimal to no scarring at the
donor site: Epidermal skin grafting (ESG). ESG is the transplantation of
autologous epidermal cells from a donor site to a wound (acceptor site), to
promote wound healing in patients with secondary healing wounds. However, this
application hardly is not followed at the time because harvesting sufficient
epidermal cells is not easy. Recently, a new epidermal cell harvesting device
(CelluTome; Kinetic Concepts, Inc, San Antonio, Texas) is on the market. The
device creates epidermal micrografts with minimal damage to the donor site and
minimal pain during and after graft harvesting. Moreover, ESG does not require
an operating room and hospitalization. This harvester, which simultaneously
applies both heat and negative pressure to normal skin, is used to produce
epidermal micrografts that subsequently are placed on the wound. Observational
studies unanimously point to a positive effect on wound healing. However, since
most wounds tend to heal, it is still unknown to what extent the healing effect
can be attributed to ESG because comparative studies into the effectiveness of
ESG are lacking.
Study objective
The aim of this study is to determine whether the alleged positive effects of
ESG on acute surgical wounds as well as ESG effects on chronic wounds are
attributable to this intervention.
Study design
Study design:
Open-label randomized controlled trial.
The open-label design is unavoidable because the intervention is a different
(in the acute- and chronic wound group indicated for SSG), or an additional (in
the acute wound group indicated for secondary healing), procedure to the
standard treatment. We aim to randomize the effectiveness of ESG compared to
standard treatment and choose two homogeneous populations of chronic- and acute
wound patients.
Study duration:
We expect to have included the required number of patients 18 months after the
start. This does not include the 6-month long-term follow-up during which the
patient is called.
Setting:
Acute wound patients with a secondary healing donor site: Department of Plastic
and Reconstructive Surgery at Erasmus MC. The ESG starts 1 week after the
intervention.
Chronic wound patients who need wound coverings: Department of Dermatology of
Erasmus MC.
In both cases, the Nursing Specialist Wounds (VS-w) carries out the ESG in the
outpatient clinic.
Intervention
ESG is the intervention in both groups. ESG is a one-time transplant of
epidermal cells from elsewhere on the patient's body (the donor site) to the
wound (the acceptor site).
• In the acute wound group, the intervention group will receive an ESG at the
1st outpatient visit 1 week after surgery. The control group will either
receive a SSG or secondary wound healing as indicated by the surgeon.
• In the chronic wound group, the intervention group receives an ESG and the
control group an SSG.
Study burden and risks
Patient burden:
- extra time for a single ESG administration: 30 min.
- extra time for taking a wound photo (donor site), filling in the
questionnaires (EQ5D and Wound QoL, VAS pain and POSAS scar scale (the POSAS is
also completed by the practitioner): 4x 15 min.
Risk:
no risks: CE marked device is used within the marketing authorization area.
If the ESG (the harvested epithelial cells) don t have a take in the wound,
then:
- the acute wound group, indicated for secondary, healing further will undergo
secondary healing (equal to the control group).
- the acute wound group, indicated for SSG, will receive a SSG (equal to the
control group).
- the chronic wound group, indicated for SSG, misses the supposed value of the
ESG treatment and then will receive an SSG (equal to the control group)
Wijtemaweg 80
Rotterdam 3015 CN
NL
Wijtemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
-all patients who are sheduled to receive a skin transplant following skin
cancer excision surgery; all patients suffering from a chronic ulcer who are
sheduled to receive a SSG (split skin graft)
Exclusion criteria
-the patient suffers from an oncologic ulcer in the wound area
-the patient is known with alcohol or drug abuse
-the patient cannot be informed correctly (e.g. because of language or mental
problems)
-the patient is unable to travel to the outpatient clinic for follow up visits
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74036.078.20 |