Chatterjee S, Sen S, Hazra A, Das AK, et al.
Indian journal of pharmacology. Date of publication 2019 Sep 1;volume 51(5):316-322.
1. Indian J Pharmacol. 2019 Sep-Oct;51(5):316-322. doi: 10.4103/ijp.IJP_237_17.
Epub 2019 Nov 26.
Randomized controlled trial of topical mupirocin versus mupirocin with
sucralfate combination in chronic skin ulcers.
Chatterjee S(1), Sen S(2), Hazra A(1), Das AK(1).
Author information:
(1)Department of Pharmacology, Institute of Postgraduate Medical Education and
Research, Kolkata, West Bengal, India.
(2)Department of Dermatology, Institute of Postgraduate Medical Education and
Research, Kolkata, West Bengal, India.
OBJECTIVES: The objective of this study was to carry out a head-to-head
comparison of topical sucralfate combined with mupirocin versus mupirocin alone
in the treatment of chronic skin ulcers with respect to both effectiveness and
safety.
MATERIALS AND METHODS: A parallel-group, open-label, randomized, controlled
trial (CTRI/2015/12/006443) was carried out with patients suffering from skin
ulcers of Wagner grading 1 or 2 persisting for over 4 weeks. Ninety-six patients
were recruited in total, and the modified intention-to-treat analysis dataset
included 44 participants treated with mupirocin 2% and 46 treated with combined
mupirocin 2% and sucralfate 7% ointment. Both medications were applied topically
thrice daily for 6 weeks. Ulcer area assessed using millimeter graph paper and
wound infection score assessed on a three-point scale were effectiveness
measures. Treatment-emergent adverse reactions that were reported by patients or
observed by the investigators were recorded.
RESULTS: The median ulcer area was significantly reduced in the combined
treatment group at the end of treatment. Clinically, 41.3% of the participants
in the combined group showed complete ulcer healing at 6 weeks compared to
18.18% in the mupirocin alone group (P = 0.022). The wound infection score
declined significantly from baseline by the end of 3 weeks of treatment in both
the groups. The frequency of qualitative wound attributes, namely pain,
discharge, and erythema, remained comparable between the groups except for
discharge which disappeared completely from all remaining ulcers in the combined
group but was still present in 11.36% of the participants treated with mupirocin
alone (P = 0.025) at 6 weeks. Adverse events were few, all local, mild, and
tolerable.
CONCLUSIONS: The wound healing effect of topical sucralfate adds to the
antimicrobial effect of mupirocin toward the overall improvement of chronic skin
ulcers. The effect of combined topical treatment needs comparison with other
topical medications and wound healing strategies.
Copyright: © 2019 Indian Journal of Pharmacology.
DOI: 10.4103/ijp.IJP_237_17
PMCID: PMC6892012
PMID: 31831920 [Indexed for MEDLINE]
Conflict of interest statement: There are no conflicts of interest.
