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Free Paper Session: Devices and Intervention
67
ARTERIOGENESIS IN ISCHEMIC WOUNDS USING ARTERIAL ASSIST
COMPRESSION PUMPS
Edward Arkans 1 , Andrew Nicolaides 3 , Paul van Bemmelen 2 , Christoffer Lattimer
1 ACI Medical (San Marcos, United States);
2 Vascular Screening Diagnostic Center (Nicosia, Cyprus);
3 Temple University (Philadelphia, United States).
Aim: To review the technology and clinical research supporting formation of collateral
arteries in critically ischemic limbs using a form of intermittent pneumatic compression.
Methods: Randomized controlled trials and physiological studies are reviewed and
discussed.
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Free Paper Session: Devices and Intervention
WOUND DECHRONIFICATION WITH NEGATIVELY CHARGED MICROSPHERES
– FINAL Results OF A RANDOMIZED, PROSPECTIVE, DOUBLE BLIND,
MULTICENTERED STUDY
Yaron Shoham 1 , Leonid Kogan 2 , Jerry Weiss 3 , Eran Tamir 4 , Yuval Krieger 1 ,
Yoav Barnea 5 , Eli Regev 6 , Natalia Haikin 2 , Amir Inbal 7 ,
Alexander Bogdanov-Berezovsky 1 , Eldad Silberstein 1 , Gabriel Zeilig 8
1 Department of Plastic and Reconstructive Surgery and Burn Unit, Soroka University
Medical Center (Be’er Sheva, Israel);
2 Plastic Surgery Unit, Western Galilee Hospital (Naharia, Israel);
3 Division of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center
(Tel Aviv, Israel);
4 Maccabi Health Services (Tel Aviv, Israel);
5 Breast Reconstruction Unit, Tel Aviv Sourasky Medical Center (Tel Aviv, Israel);
6 Hard to Heal Wounds Clinic, Sheba Medical Center (Tel Hashomer, Israel);
7 Plastic and Reconstructive Surgery Department, Tel Aviv Sourasky Medical Center (Tel
Aviv, Israel);
8 Neurological Rehabilitation Department, Sheba Medical Center (Tel Hashomer, Israel).
Aim: We report the final analysis of a multicenter, prospective, double-blind, randomized
controlled study comparing the efficacy and safety of Negatively Charged Microspheres*
(NCM) to control (saline soaks) in the treatment of hard-to-heal wounds of different
etiologies.
Methods: Patients with at least one hard-to-heal wound, defined as refractory to healing
for at least four weeks, or wounds with exposed bones, tendons or ligaments, were
eligible for the study and randomized to NCM or control, both applied twice daily for four
weeks. Patients were monitored bi-weekly for eight additional weeks while treated by
standard wound care at the investigators’ discretion. The primary endpoint was defined
as coverage of >75% of the wound area by light-red granulation tissue after four weeks
of treatment.
Results: Fifty-eight patients completed the study, 32 in the NCM group and 26 in the
control group. In the NCM group 46.9% of patients achieved >75% light red granulation
tissue after 4 weeks compared with 15.4% of patients in the control group (p=0.01). The
mean wound surface area in the NCM group was reduced by 39% after 4 weeks
compared with 14.9% in the control group (p=0.02).
Conclusion: This study demonstrates that compared to control treatment, NCM
treatment of hard-to-heal and chronic wounds improves formation of healthy granulation
tissue and reduces wound size by ”dechronifying” the chronic wounds and “kick-starting”
the healing process.
* NCM is distributed as PolyHeal by MediWound LTD
Results: Permanent improvements are demonstrated by healed wounds (97%),
resolved rest pain (100%), limb salvage (86–94% at 1.5 to 3.5 years), increased toe
pressure (15.5mmHg), increased popliteal artery flow (20.5 cm/sec) and formation of
collateral arteries with angiographic evidence.
Discussion: There are few medical treatments available to patients with critical limb
ischemia unable to undergo surgical intervention. A body of evidence has emerged that
shows how collateral artery growth (arteriogenesis) is created. Arterial assist pumps
rapidly apply high pressures to the foot, ankle and calf.
There are several mechanisms of action identified by which these pumps support
arteriogenesis for chronic improvement and acutely increase tissue blood flow for more
immediate ischemic pain relief. 1. The arterial-venous pressure gradient is increased. 2.
The induced endothelial shear stress releases nitric oxide and causes arteriolar
vasodilatation and reduced peripheral resistance. 3. Longer term usage leads to
expression of growth factors responsible for collateral formation and permanent
reduction of ischemia.
Conclusions: Limb salvage studies on non-reconstructable patients show significantly
reduced major amputation rates with wound healing and elimination of rest pain. Earlier
randomized controlled trials showed permanent improvements in pain free walking
distance for claudicants. Results were as good as or better than those obtained in
supervised exercise programs.
FREE PAPER SESSION: DEVICES AND INTERVENTION
EWMA 2013
COPENHAGEN
15-17 May · 2013
Danish Wound
Healing Society
53