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ID
Source
Brief title
Health condition
patients with clinically deep burn or deep skin defect between 4% and 20% TBSA
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. 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
admission and at 3 and 12 months follow up.
9. 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.
10. 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
11. 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.
12. Incidence of AE and SAE
- An Adverse Event (AE) is any untoward medical occurrence in a subject who is participating in a clinical study performed.An AE can be any
unfavourable and unintended sign (including an abnormal laboratory or vital sign finding), symptom, or disease temporally associated with the
study participation, whether or not it is related to the study.
- A Serious Adverse Event (SAE) is an event that is:
a) fatal
b) life-threatening
c) results in persistent or significant disability/incapacity
d) requires or prolongs inpatient unexpected hospitalization
e) is a congenital anomaly or birth defect or
f) is a medically important event.
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 intra-patient controlled trial to compare long-term scar quality of both skin grafting techniques is highly preferred.
Study objective
Our hypothesis is that treatment with micrografting, when compared to conventional meshed graft, will result in a better scar quality and smaller donor site size.
Study design
During admission, 3 months and 12 months after operation
Intervention
Prior to surgery two comparable (burn) wounds or two equal parts in one (burn) with a minimum size of 36 cm2 will be selected. These wounds will be randomly allocated to the intervention method (micrografting) or the comparison method (meshed skin grafting).
Inclusion criteria
• Patients ≥18 years
• Clinically deep burn or deep skin defect between 4% and 20% TBSA
• Patients with two comparable deep partial thickness and/or full thickness burns, confirmed by laser Doppler imaging (LDI) or deep skin defects, of minimum 1:2 plissee = 36cm², requiring surgery after assessment by a (plastic) surgeon/burn physician
• Patients who are mentally capable to give legal consent or legal representative when the patient is temporarily incompetent (e.g. patient is sedated/ventilated)
Exclusion criteria
• Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
• Wounds covering face, hands or joints
• Patient has one or more medical condition(s) that in the opinion of the treating physician would make the patient an inappropriate candidate for this study
• Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8847 |
| Other | METC VU medical centre : METC 2020.471. |