ultrathin graft in threatment of doabetic foot ulcerppt.PPT

ultra thin skin grafting in diabetic foot ulcer

1. Role of Ultrathin Skin Graft in Early Healing of
Diabetic Foot Ulcers: A Randomized Controlled
Trial in Comparison With Conventional Methods
Presenter: DR.VAMSIDHAR (PG-2,GEN SURG)
Moderated by: DR. RITA SINGH (prof,GEN SURG)

2. Introduction
•With a rising prevalence worldwide, diabetes mellitus (DM) is a burden on the
health care systems.1 Diabetes mellitus is becoming more common; the number of
people living with DM increased 1.5 fold from 463 million, and the prevelance is
expected to reach 700 million in 2045.
•After China, India has the second-highest population of individuals with diabetes.
•Diabetes is associated with multiple complications, including diabetic foot ulcers
(DFUs).

3. •According to the International Working Group on the Diabetic Foot
(IWGDF), a DFU is a full-thickness wound passing through the dermis
and located below the ankle in a patient with diabetes.
•It is estimated that 15% of patients with DM will experience a DFU in
their lifetime⁵; if these patients are not treated in a timely manner, a DFU
can progress to infection, osteomyelitis, or gangrene, which can lead to
amputation.

4. •As many as 8 in 10 nontraumatic amputations can be attributed to
DM, and 85% of such amputations result from DFUs.
•Mortality after unilateral limb amputation varies, with the risk
between 13% and 40% at 1 year, between 35% and 65% at 3 years,
and between 39% and 80% at 5 years.However, it has been
estimated that the majority of these amputations can likely be
prevented

5. •Microangiopathy is one of the main pathologic conditions underlying the slow,
insufficient, or nonhealing nature of a DFU.7 Other pathologic conditions include
decreased or impaired growth factor production, collagen accumulation, and
quantity of granulation tissue.

6. •Conventional treatment methods involve initial debridement and multiple
dressings. Treatment could include repeat debridements and a long follow-
up period until complete wound is achieved; long follow-up period is
considered to exceed 3 months in this study. Many wounds take longer
than expected to heal, resulting in an increased morbidity rate and health
care costs. The estimated 5-year mortality is up to 30.65%, and the cost
burden is equivalent to that of cancer

7. •Standard therapy for managing DFUs involves glycemic control, antibiotic
coverage, debridement of necrotic tissue, regular dressing changes, and
offloading footwear. Several recent modalities have been introduced, such as
various types of dressing, including negative pressure wound therapy (NPWT),
offloading, growth factor application, and bioengineered skin constructs.
•Although NPWT shows promising results, it has disadvantages such as the need
for multiple sittings, foam dressing fragmentation and u, and difficulty
maintaining effective suction. There may be a requirement for a definitive skin
grafting procedure for coverage to encourage complete healing

8. •Split-thickness skin grafting (STSG) can be used to manage and close DFUs. Still, it can be
used only when the wound bed is healthy, with sufficient granulation tissue, which in turn
could demand multiple, regular saline-gauze dressings or NPWT applications.Often, even
STSG may not be sufficient
•Conventional treatments for DFUs could be associated with more hospital visits and a
longer healing time, which would add to the patient’s health care cost and potentially affect
their overall quality of life. The cost involved, availability of the treatment, and frustration
with the lack of healing can significantly affect patient adherence

9. •In a prospective study, Hachach-Harametal20 proposed a method of epidermal
grafting using an automated tool (epidermal graft harvesting device;
CELLUTOME Epidermal Harvesting System; 3M) in an outpatient setting,
resulting in minimal or no pain and a scar-free donor site. A case series based in
India demonstrated promising results of epidermal grafting as a potentially
suitable option for managing chronic, complex wounds when only the epidermal
layer is required.

10. •The epidermal skin graft has only been previously used on a wound in
which the wound bed had sufficient granulation tissue formation (before
multiple dressings or NPWT applications were used for wound bed
preparation)

11. Ultrathin grafting
•Prior to grafting, the wound was debrided, necrotic patch and slough were excised,
the wound edge was freshened, and thorough saline irrigation was performed. In
addition to the wound being completely debrided, thorough irrigation was
performed after complete hemostasis had been achieved.
•As is typical, the graft was taken from the opposite thigh. The donor site was
cleaned, prepped, and draped. Saline was injected into the subepidermal plane using
a 10-mL syringe to separate the superficial epidermis and deeper dermis. The
amount of saline injected depends the graft size required. Emollient liquid paraffin
was applied on the top to facilitate easy gliding of the blade.

12. •The Watson modification
of the Humby knife with
the lowest blade setting
was used for graft
harvesting . To confirm
the UTSG, the ultrathin
graft was
macroscopically
identified by its
transparent nature and
punctuated minor bleed
at the donor site.

13. •The graft was applied over the wound and fixed with multiple staples to
ensure contact between the graft and the wound bed. The wound was
dressed with petrolatum gauze, followed by applying a nonadherent soft
pad with a soft cloth backing. An 8-layer plaster of Paris slab was used to
immobilize the ankle joint. The donor site was covered with petrolatum
gauze, and a tight compression dressing was applied. The wound dressing
was first opened on postoperative day 5 and subsequently as required
(usually every third day). Staples were removed after 10 to 14 days

14. Conventional dressing
•The control group underwent initial debridement and multiple regular
saline-gauze dressings. Local debridement of slough on an outpatient basis
was done at each visit if required. Patients were observed for progression
to abscess or osteomyelitis, and the presence of either resulted in
immediate debridement or amputation

15. Study outcome
•The primary endpoints were complete healing of the wound after grafting or completion
of the study period (12 weeks). Secondary endpoints included wound-related adverse
events (eg, progression of infection) leading to interventions such as amputation during
the study period.
•Wound healing was assessed clinically, with wound measurement recorded using the
wound analysis software at each visit. High-quality, accurate, standardized images for
digital measurement of the wound surface area were obtained and stored in the digital
photograph diary.

16. Caption

17. •Study outcomes measured were time to wound healing, total number of
hospital visits and cost of treatment, final outcome of the wound, and the
incidence of adverse events occurring within the duration of the study.
Furthermore, the authors determined the wound-healing mechanism of
UTSG by analyzing histopathologic reports of the wound bed tissue biopsy
to assess improved granulation tissue and vascularity of the wound bed.

19. Randomization, allocation concealment, and blinding
•Once consent was obtained, patients were randomly assigned to either the test group
or the control group. A random allocation sequence was computer generated using
SPSS. The allocation sequence was sealed in identical opaque envelopes and given to
the enrolling researcher upon receipt of patient consent
•Sample size
•The present pilot study was given a significance level of .05 for 80% power, yielding
a sample size of 26 patients per group. The goal was to recruit a total of 52 patients
into the study

20. Data collection
•All data collected were recorded on paper forms and in a digital folder. The
surgical team and trial personnel collected data. A research fellow ensured the
accuracy of the data collection by performing sample assessments at regular
intervals. Any adverse events were recorded and reported to the primary
investigators as well as the institutional ethics committee.

21. •Wounds were assessed and recorded in a wound assessment form at each
visit. The wound analysis software applied to photographic images was
used to measure the wound surface area digitally. The number and cost of
outpatient visits were recorded, and the type and cost of the dressings used
were documented.
•Calculation of the total cost of treatment included the cost of hospitalization
as well as the procedure charge and dressing charges at each subsequent
hospital visit.

22. Results
•A total of 56 patients were enrolled in the study. Of these, 3 were lost to
follow-up before 12 weeks, and 1 patient received collagen dressing at the
local clinic. Thus, 4 patients (2 from each group) were ineligible for inclusion.
Data from 52 patients (26 in each group) were analyzed. Age distribution
among both groups was statistically matched with the mean age in the test
groups.

23. •Sex distribution was matched, with 11 males and 15 females in the test
group and 14 males and 12 females in the study group.
•Among 52 patients, 4 had associated PVD and were undergoing
conservative management as per the advice of the vascular surgeon. Two of
these patients were in the test group, and 2 were in the control group.

24. •Wound severity was measured using the PUSH tool. Before intervention, the mean
wound score was 14.42 in the test group and 14.27 in the control group, which was
statistically comparable. Before intervention, the mean wound size was 54.85 cm2 ±
47 in the test group and 39.38 cm2 ±17.58 in the control group .
•At week 6, the mean wound size had decreased to 25.08 cm2 ±39.29 in the test
group and 28.69 cm2 ±17.56 in the control group . At week 12, the mean wound size
had further reduced to 9.08 cm2 ±27.62 in the test group and 27.68 cm2 ±16.88 in
the control group.

26. •At week 6, there was a 54.50% reduction in mean wound size observed in the
test group, and a 27.14% reduction in mean wound size noted in the control
group. At week 12, the reduction in mean wound size was 83.44% in the test
group and 29.68% in the control group compared with the preintervention
wound size

27. •Complete wound healing was achieved in 22 of 26 patients (84.61%) in the
test group and 14 of 26 patients (53.84%) in the control group during the 12-
week study period. The mean time to heal was 6.22 weeks in the test group.
•The mean number of hospital visits was 9.2 in the test group and 11.07 in the
control group. Four patients in the test group required more than 12 visits
(15.38%), and 13 patients in the control group required more than 12 visits
(46.15%).

28. •The total cost of the intervention was less than 15  000 INR ($198 US)
for 11 patients in the test group and 9 in the control group, 15 000 INR
($198 US) to 30 000 INR ($397 US) for 9 patients in the test group and 5
in the control group, and more than 30 000 INR ($397 US) for 6 patients
in the test group and 12 in the control group (P =.001 [Fisher exact test]).

29. •Complete graft loss was noted in 2 patients, which was expected owing to
association with PVD. However, in these cases, the present authors observed
clinical signs of wound healing (ie, increased granulation tissue and
hyperemia), which allowed repeat grafting with STSG. Later wounds healed
completely without any complications. From the results of the current study,
the ultrathin graft did not persist in the wounds but seemed to have a long-term
effect on tissue regeneration. It appears the ultrathin graft is essential for
initiating tissue repair but is dispensable after the patient’s cells are
activated.

30. •No significant complications were noted at the graft harvest site wound.
Two patients had delayed spontaneous healing.
•Histopathologic examination of a wound bed tissue biopsy taken before
intervention and 3 weeks after UTSG showed a comparative increase in
granulation tissue and tiny blood vessels in the test group

31. Discussion
•Wound care for those with diabetes is a significant financial and resource
burden on the health care system, which signifies a need to further
optimize current wound coverage strategies.22,23 Epidermal grafting for
wound healing is not a new concept. Several case reports have indicated
good wound healing outcomes

33. •Similarly, automated epidermal graft also proved useful when STSG was
contraindicated because of concern for poor wound healing at the donor site, such as in
the case of pyoderma gangrenosum.
•Molecular studies of the epidermal graft using an automated epidermal harvesting tool
showed that epidermal micrografts formed at the dermal-epidermal junction secrete
various growth factors essential to wound healing, including platelet-derived growth
factor, VEGF, and granulocyte colony-stimulating factor,19,30 thereby encouraging the
wound bed to regenerate and initiate keratinocyte migration from the edges of the
wound.

34. •The migrating keratinocytes also deposit a variety of extracellular matrix
components, such as laminin, fibronectin, and type IV collagen.
•These findings are consistent with the observation of the authors of the current
study that when the epidermal graft was transplanted, wound healing occurred
simultaneously within the wound bed and margins. These islands of
reepithelialization eventually merged to form a confluent structure, which
suggests a unique molecular mechanism of epidermal grafts and warrants
further investigation.

35. •Wound healing and healing time were key outcomes measured, and the results
demonstrate that 84.61% of the wounds in the test group fully healed. More than
50% of wound healing was achieved within 6 weeks, and complete wound closure
was achieved within a mean of 6.2 weeks. Of the wounds that were not healed in
the study population, the majority (75%) were in the control group, which may
imply that the epidermal grafts stimulate the healing process in hard-to-heal
wounds.

36. •Also, in patients with DFUs with mild PVD being managed
conservatively, the current study demonstrated the efficacy of UTSG by
improving wound healing in terms of improved granulation tissue and
hyperemia of the wound bed. The primary aim was to demonstrate an
improved wound bed, which was easily accomplished, after which the
wound was covered with STSG, and complete wound closure was
achieved.

37. •Ultrathin skin grafting serves an important role in improving the healing process of the
wound bed and acting as a primary cover for wound closure in most cases. Some cases
may require additional STSG for definitive wound closure, which shows promising
results due to enhanced healing process by prior UTSG. In the authors' opinion, most
wounds healed with UTSG, but in some cases, an additional STSG may be necessary.
However, the use of UTSG prior to definitive STSG would help to increase granulation
tissue and help with STSG uptake.
•Ultrathin skin graft donor site complications can be avoided, such as infection, pain, and
hypertrophic scarring. None of these donor site-related complications occurred in the
current study.

38. Conclusions
•Ultrathin skin grafting offers early healing of DFUs owing to its growth factor–
secreting ability and acts as a primary cover for wound closure. It also requires
fewer hospital visits and has a lower total treatment cost compared with
conventional dressing treatment. Ultimately, UTSG improves the final outcome
of the wound. It is a more straightforward technique than other recent treatment
modalities, has a short learning curve, and requires no special equipment other
than standard instruments. Cost-effectiveness and availability promote patient
adherence to treatment, which makes up for poor follow-up with other
treatments.

39. •Ultrathin skin grafting offers a new modality in managing DFUs, which
is more feasible than conventional frequent dressing changes
Journal byDR.Rahul Shetty
DR.BS Giridhar
DR.Ankush Potphode
DOI: 10.25270/wnds/2022.5767