Omar AA, Mavor AI, Jones AM, Homer-Vanniasinkam S, et al.
European journal of vascular and endovascular surgery : the official journal of the European So.... Date of publication 2004 Jun 1;volume 27(6):666-72.
1. Eur J Vasc Endovasc Surg. 2004 Jun;27(6):666-72.
Treatment of venous leg ulcers with Dermagraft.
Omar AA(1), Mavor AI, Jones AM, Homer-Vanniasinkam S.
Author information:
(1)Department of General Surgery, Faculty of Medicine, Shebinel-Kom, Egypt.
BACKGROUND: A number of different treatment approaches have been recommended for
the treatment of venous ulceration, including local ulcer treatment, compression
and drug therapy. Recent advances in tissue engineering have resulted in living
tissues being developed for cutaneous wound repair and skin replacement. The aim
of this pilot study was to compare the rate of healing of venous ulcers in
patients treated with Dermagraft (a human fibroblast-derived dermal replacement)
and compression therapy or compression therapy alone.
METHODS: A total of 18 patients with venous ulceration of the leg were recruited
into the pilot study. Ten patients were treated with Dermagraft and compression
therapy, and eight patients were treated with compression therapy alone. Healing
was assessed by ulcer tracing and computerised planimetry. Skin perfusion was
measured by laser Doppler.
RESULTS: Five (50%) of the patients treated with Dermagraft and one (12.5%)
control patient had healed by the end of the 12-week study period (NS). The total
ulcer area rate of healing and linear rate of healing was significantly improved
in patients treated with Dermagraft (P=0.001 and P=0.006, respectively,
Mann-Whitney U-test). The number of capillaries increased in both the treatment
and control group. Peri-ulcer skin perfusion increased by 20% in patients treated
with Dermagraft, compared with 4.9% in the control group.
CONCLUSION: The data from this small pilot study suggests that Dermagraft is
associated with improved healing of venous ulceration. Following this pilot
study, further clinical studies are needed to confirm the validity of these
results in 'hard to heal' venous leg ulcers.
DOI: 10.1016/j.ejvs.2004.03.001
PMID: 15121121 [Indexed for MEDLINE]