To assess long-term scar quality of deep/sub dermal (burn) wounds after skin grafting with micrografting technique compared to meshed grafting technique.
ID
Source
Brief title
Condition
- Other condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Health condition
(brand)wonden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Long-term scar quality 12 months after skin transplantation assessed with the
Patient and Observer Scar Assessment Scale (POSAS).
Secondary outcome
1. Long-term scar quality 3 and 12 months after skin transplantation
- Possible differences in scar quality between micrografting or meshing
technique will be assessed 3 months post-operative at the outpatient
clinic. Color and pigmentation are objectively measured with the Mexameter
or Dermaspectrometer and skin elasticity with the Cutometer.
Subjectively assessment of the scar will be conducted by both researcher
and patient with the Patient and Observer Scar Assessment Scale
(POSAS).
2. Donorsite size and ratio of donorsite size and actual graft size (cm2)
- Surface areas will be calculated with a 3D-camera (Woundworks inSight)
3. Take rate of skin grafts
- Take rate will be clinically assessed at 8 +/- 2 days and expressed as
the percentage of micrografted and meshed graft take
4. Healing time
- Clinical assessment of wound healing 14 and 21 days +/- 2 post
application expressed as percentage of the total wound surface area healed
- Time to complete wound closure where complete wound closure is defined as
> 95% re-epithelialization of the wound with the absence of drainage
and no longer needing a substantial wound dressing
5. Bacterial load
- Wound swabs for semi-quantitative investigation
- Semi-quantitative bacteriology in both groups
- Percentage of patients within both groups with clinical wound infection
requiring systemic antimicrobial
therapy.
*Clinical infection* is defined as the presence of cellulitis and/or
visible purulence and/or lymphangitis combined with one or more of the
following:
local wound pain/erythema/edema/malodor.
6. Pain
- Will be evaluated in the autografted target wounds with help of a Visual
Analogue Scale (VAS score) on day 2 post surgery, before and after
removal of Surfasoft®/Urgotul in case of meshed skin grafts or plissees
in case of micrografting, and thereafter once weekly during the
hospitalization period. After hospital discharge pain will be evaluated
again at the 3 and 12 months follow ups
7. Number of secondary procedures
- Re-interventions in study areas due to insufficient take or necessity of
reconstructive surgery.
8. Mobility at 3 and 12 months
- If articulations of limbs are involved the Quick Dash for upper
extremities and the Lower extremity functional scale for lower extremities, the
range of motion will be assessed with a goniometer.
9. Quality of life
- Assessed at the time of hospital discharge and at 3 and 12 months after
the procedure. 3 quality of life measures, the EQ5D-5L, SF36 and DLQI
will be used at different points in time: at the time of hospital
discharge and 3 and 12 months post wound healing
10. Health economics:
- Differences in operation time, costs of materials/equipment used and
staff/personnel and impact of re-interventions and the need for
reconstructive surgery will be evaluated. Using regression analysis
based on the processing of the EQ5D-5L, SF36 and the DLQI we will be
able to construct an economic model. The model will incorporate the
short-term costs involved of both skin expansion techniques as well as
the long- term costs.
11. Incidence of AE and SAE
- There are no Adverse Events (AEs) expected, relating to this study
(comparison of two already existing types of skin grafting
- A Serious Adverse Event (SAE) is any untoward medical occurrence in a
subject who is participating in a clinical study performed. This is defined as
an event that is:
a) fatal
b) life-threatening
c) requires or prolongs inpatient unexpected hospitalization
- These SAEs will be reported directly to the METc.
- SAEs related to surgery in general will be noted in a line-listing and
will be reported yearly to the METc. These are defined as an event that results
in a:
a) pneumonia
b) urinary tract infections
c) sepsis
d) pulmary embolism
e) re-operation
12. Skin graft technique preferred by patient
- Patient gives overall indication as to what skin graft technique he/she
would prefer if he/she were to require skin grafting again: weekly during
hospital admission and 3 and 12 months follow up.
Background summary
Patients with deep dermal/subdermal (burn) wounds often have an indication for
a skin transplantiation. Most common method is split skin grafting (SSG).
Surface area of the skin graft is mostly expanded to retain a small donorsite
(wound after harvesting of the skin graft). Skin graft expansion is generally
performed by the meshed skin grafting technique, seen this method is considered
to be quick and easily applicable. Yet, this technique also has several
limiations. For the surgeon this method becomes more cumbersome when the
expansion ratio increases. Moreover, the actual expansion of the skin graft is
usually lower then the intended expansion ratio and the "fish-net" pattern
often stays visible in the eventual scar. An alternative for skin graft
expansion is the micrografting technique (Meek technique). In comparision with
meshed skin grafting this technique is able to reach large expansion ratio's
and thereby maintain small donorsites. As a consequence, this technique is used
in particular for very extended (burn) wounds. Both expansion methods are used
worldwide in specialized burn centers. Wound healing seams to be similar
according to previous published literature. Experience shows an possible
advantage of micrografting on scar quality. Three studies compared these two
expansion techniques, however none primarily investigated possible differences
within long-term scar quality. Given the increasingly prominent role of scar
quality in (burn) wound care, a randomized controlled trial to compare
long-term scar quality of both skin grafting techniques is highly preferred.
Study objective
To assess long-term scar quality of deep/sub dermal (burn) wounds after skin
grafting with micrografting technique compared to meshed grafting technique.
Study design
Multicentre randomized intra-patient controlled trial.
Intervention
Prior to surgery two comparable (burn) wounds or two equal parts in one (burn)
with a minimum size of 36 cm2 per wound will be selected. These wounds will be
randomly allocated to the intervention method (micrografting) or the comparison
method (meshed skin grafting).
Study burden and risks
All patients will have to undergo surgery, independent of skin grafting method.
Seen both skin grafting techniques are already been considered as standard
treatments, there is no additional risk micrografting compared to meshed skin
grafting. Follow-up broadly corresponds with standard follow-up for (burn)
wounds. The duration of check-up at outpatient clinic is slightly increased to
60 minutes, due to additional examinations and surveys. Moreover, as mentioned
above possible subtle asymmetry of the scar is a risk.
Heymanslaan 10
Gent 9000
BE
Heymanslaan 10
Gent 9000
BE
Listed location countries
Age
Inclusion criteria
- 18 years and older
- deep burn or deep skin defect requiring skin grafting
- two comparable deep partial and/or full thickness burns, confirmed with Laser
Doppler Imaging, or deep skin defect, of a minimum of 36 cm2 per wound,
requiring skin grafting after assessment of a (plastic) surgeon/burn physician
- mentally capable to give legal consent or legal representative when patient
is (temporarily) incompetent (e.g. sedated/ventilated)
Exclusion criteria
- patient has participated in another study utilizing an investigational drug
or device within 30 days
- wounds covering face, hands or joints
- patient has one or more medical condition(s) that in the opinion of treating
physician would make the patient an inappropriate candidate for this study
- patient who is expected (according to the responsible physician) to be
non-compliant to study protocol. (This includes patients with severe cognitive
dysfunction/impairment and sever psychiatric disorders).
Design
Recruitment
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 | NL74274.029.20 |