The Use of Dehydrated Human Amniotic Membrane (dHACM

The Use of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts to Expedite Healing in Patients with Five
Major Types of Refractory Non-Healing Wounds: A Cohort Study
Darshan Nagesh, DPM; Robin Lenz, DPM; Hannah Park, DPM; Patrick Sanchez, DPM; Sarah Park, DPM; Jake Ruff, DPM; Matthew Garoufalis, DPM, FASPS, FACFAOM, CWS
Jesse Brown Veterans Affairs Medical Center, Chicago, IL
Desert Foot, November 19-21, 2014, Phoenix, AZ
Background
Methods
 Chronic non-healing wounds including diabetic foot ulcers
(DFU), venous stasis ulcers (VSU), pressure ulcers (PU),
ischemic ulcers (IU), and surgical wounds (SW) pose a
significant economic burden on the society.
 Human amniotic membrane has been used in a variety of
surgical procedures and in wound healing for many decades.
 Amniotic membrane is a non-vascular tissue consisting of
epithelium cells, basement membrane, a thick compact layer
and fibroblast layer.
 The fibrous layer contains cell anchoring collagen types: I, III,
IV, V, and VII.
 Biochemical properties of the membrane help to reduce
inflammation and enhance soft tissue healing.
Study design
 Retrospective chart review from a podiatric surgery clinic of a single medical
center.
Included
 66 patients with lower extremity wounds (DFU, VSU, IU, PU, SW) who failed
(<50% reduction) with Standard of Care for 4 weeks.
Treatment
 Weekly application of dHACM after sharp/mechanical debridement as
deemed necessary in conjunction with offloading (PU, DFU, SW),
compression therapy (VSU), and vascular surgical intervention/ArtAssist® as
deemed appropriate for IU.
 Weekly dressing change and graft application was performed in our
outpatient clinic.
Analysis
 Weekly wound measurements were obtained post debridement in the clinic
during follow-up visits.
 Rate of closure using dHACM was calculated for the five major types of
wounds.
 Percent area reduction to current date was calculated for wounds not
completely epithelialized.
Dehydrated Human Amnion/Chorion Membrane (dHACM)
 Dehydrated human amnion/chorion membrane (dHACM)
allografts have become a popular commercially available skin
substitute.1
 The material is cleaned, dehydrated, and sterilized by the
proprietary PURION® Process that produces an easy to use
allograft with a 5 year shelf life at ambient conditions.1
 PURION® Processed dHACM has been shown to retain
biological activities related to wound healing, including the
potential to positively affect four distinct and pivotal
physiological processes intimately involved in wound healing:
cell proliferation, inflammation, metalloproteinase activity, and
recruitment of progenitor cells.2
 Randomized controlled trials and clinical studies have
established dHACM as an effective treatment for diabetic foot
ulcers and venous leg ulcers.3-6
Purpose
 The main purpose of this study is to show the effectiveness of
dHACM in treating refractory non-healing wounds of various
etiologies.
dHACM = AmnioFix® and EpiFix,® MiMedx Group, Inc., Marietta, GA
AmnioFix®, EpiFix®, and PURION® are registered trademarks of MiMedx Group, Inc.
ArtAssist® is a registered trademark of ACI Medical Management, Inc.
Results
Table 1. Summary of healing in patients with 5 major types of wounds.
Wound Type
Total # of
Patients
# of Patients with
Complete Data
Average Age of
Wound (wks)
Neuropathic (DFU)
18
14
22.9
.75 cm2
4
Venous stasis ulcers (VSU)
17
16
23.1
3.94 cm2
5.19
Pressure Ulcers (PU)
7
6
9.1
8.35 cm2
8.66
Ischemic Ulcers (IU)
3
3
5.3
.23 cm2
3
Surgical wounds (SW)
21
20
11.2
7.22 cm2
6.1
66
59
16.9
4.41 cm2
5.4
Overall
Pre dHACM
Average Wound Average # of dHACM
to Heal
Size
Healed
Case 1. Surgical Wound
Results
 Overall, the average wound size was 4.41 cm2.
 Of the 66 patients, 6 patients were not included secondary to either loss to
follow-up or complications. One patient with a PU was being treated with
dHACM at the time of chart review and showed a 91.7% size reduction after
6 consecutive weekly applications.
 There were statistical differences in the average size of the wounds between
the major wound types in our cohort (p=0.0015), and a statistically
significant difference in the number of applications to wound healing
between the groups of major wound types (p=0.0004).
Conclusion
 dHACM can significantly expedite healing in different types of refractory
wounds concomitantly while addressing the underlying etiology of the
wounds.
Case 2. Surgical Wound
References
Case 3. DFU
1. Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound
management. Wounds 2012;24(10):299-307.
2. Koob TJ, Rennert R, Zabek N, et al. Biological properties of dehydrated human amnion/chorion composite graft:
implications for chronic wound healing. Int Wound J 2013 Oct;10(5):493-500.
3. Zelen CM. An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. J Wound Care.
2013a;22(7):347-348, 350-351.
4. Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomized comparative parallel study of amniotic
membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013;10(5):502-507.
5. Zelen CM, Serena TE, Snyder RJ. A prospective, randomised comparative study of weekly versus biweekly application of
dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Int Wound J.
2014;11(2):122-128.
6. Serena TE, Carter MJ, Le TL, Sabo MJ, DiMarco DT. A Multi-center Randomized Controlled Clinical Trial Evaluating the Use
of Dehydrated Human Amnion/Chorion Membrane Allografts and Multi-layer Compression Therapy vs. Multi-layer
Compression Therapy Alone in the Treatment of Venous Leg Ulcers. Wound Repair and Regeneration. 2014 Sept 15.
(epub).

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