Randomized,double-blind clinical trial comparing the healing of stasis ulcers in lower limbs with standard hydrocolloid gel dressings and with dressings with Syzygium cumini extract
Restricted accessResearch articleFirst published online July, 2022
Randomized,double-blind clinical trial comparing the healing of stasis ulcers in lower limbs with standard hydrocolloid gel dressings and with dressings with Syzygium cumini extract
To evaluate the healing of venous ulcers in the lower limbs (VLU) using dressings with hydrocolloid gel associated with Syzygium cumini extract (SHG) compared to standard hydrocolloid gel dressings (HG).
Method
This prospective, double-blind, randomized trial recruited 90 patients with VLU divided into: dressings with SHG (n = 44) and dressings with HG (n = 46). Primary endpoint was healing in the 14th visit. Secondary endpoints were healing rate, complete healing during follow-up, and improvement in the pain scale and in quality of life.
Results
There were no significant between-group differences in healing (p = 0.15). The wound area made healing difficult (p = 0.008). Age, body mass index, and wound time demonstrated a tendency to worsen the healing. Positive culture for Pseudomonas aeruginosa resulted in 88% reduction in the healing risk (p < 0.0001).
Conclusion
There was no difference between the dressings evaluated. The presence of Pseudomonas aeruginosa significantly impaired wound healing.
BergqvistDLindholmCNelzenO. Chronic leg ulcers: The impact of venous disease. J Vasc Surg1999; 29(4): 752–755.
2.
CallamMJRuckleyC V.HarperDR, et al.Chronic ulceration of the leg: Extent of the problem and provision of care. Br Med J Clin Res Ed1985; 290(6485): 1855.
3.
MaffeiFHAMagaldiCPinhoSZ, et al.Varicose veins and chronic venous insufficiency in Brazil: Prevalence among 1755 inhabitants of a country town. Int J Epidemiol1986; 15(2): 210–217.
4.
BremHKirsnerRSFalangaV. Protocol for the successful treatment of venous ulcers. Am J Surg2004; 188(1A Suppl): 1–8.
5.
MayerWJochmannWPartschH. Varicose ulcer: healing in conservative therapy. A prospective study. Wien Med Wochenschr1994; 144(10–11): 250–252. Available at:http://europepmc.org/abstract/MED/7856198(accessed 21 September 2021).
6.
O’MearaSAl-KurdiDOlogunY, et al.Antibiotics and antiseptics for venous leg ulcers. Cochrane Database Syst Rev2014; 1: CD003557.
7.
StaceyMCJopp-MckayAGRashidP, et al.The influence of dressings on venous ulcer healing‐‐a randomised trial. Eur J Vasc Endovasc Surg Off J Eur Soc Vasc Surg1997; 13(2): 174–179.
8.
NormanGWestbyMJRithaliaAD, et al.Dressings and topical agents for treating venous leg ulcers. Cochrane Database Syst Rev2018; 6(6): CD012583, Available at:http://europepmc.org/abstract/MED/29906322.
9.
O’mearaSCullumNNelsonEA, et al.Compression for venous leg ulcers. Cochrane Database Syst Rev2012; 2012(11): CD000265.
10.
SrivastavaSChandraD. Pharmacological potentials of Syzygium cumini: A review. J Sci Food Agric2013; 93(9): 2084–2093.
11.
SwamiSBThakorNSJPatilMM, et al.Jamun (Syzygium cumini (L.)): A Review of its food and medicinal uses. Food Nutr Sci2012; 03(08): 1100–1117.
12.
AyyanarMSubash-BabuP. Syzygium cumini (L.) Skeels: A review of its phytochemical constituents and traditional uses. Asian Pac J Trop Biomed2012; 2(3): 240–246.
13.
LouiseBGondimC. In vitro antibacterial and non-stick activity of extracts from leaves of Psidium guineense Sw. and Syzygium cumini (L.) Skeels on oral microorganisms. 2012; 60: 359–365.
14.
MohamedAAAliSIEl-BazFK. Antioxidant and antibacterial activities of crude extracts and essential oils of Syzygium cumini leaves. PLoS One2013; 8(4): e60269.
15.
OliveiraGF DeAraçariNCardosoJ, et al.Antimicrobial activity of syzygium cumini (Myrtaceae) leaves. Extract2007: 381–384.
16.
DamstraRJPartschH. Prospective, randomized, controlled trial comparing the effectiveness of adjustable compression Velcro wraps versus inelastic multicomponent compression bandages in the initial treatment of leg lymphedema. J Vasc Surgery Venous Lymphat Disord2013; 1(1): 13–19.
17.
RuanZPZhangLLLinYM. Evaluation of the antioxidant activity of Syzygium cumini leaves. Molecules2008; 13(10): 2545–2556.
18.
AqilFGuptaAMunagalaR, et al.Antioxidant and antiproliferative activities of anthocyanin/Ellagitannin-enriched extracts from Syzygium cumini L. (Jamun, the Indian Blackberry). Nutr Cancer2012; 64: 37–41.
19.
SianiACSouzaMCHenriquesMGMO, et al.Anti-inflammatory activity of essential oils from Syzygium cumini and Psidium guajava. Pharm Biol2013; 51(7): 881–887.
20.
ChhikaraNKaurRJaglanS, et al.Bioactive compounds and pharmacological and food applications of Syzygium cumini - A review. Food Funct2018; 9(12): 6096–6115.
21.
TurattiKF. Syzygium cumini (L.) Skeels: Quality assessment, morphoanatomical study, study of antimicrobial, preservative, genotoxic, mutagenic, and cytotoxic activity, and incorporation into cosmetic formulations for topical use. In: Graduate Program in Pharmaceutical Sciences. Araraquara: Julio de Mesquita Filho” São Paulo State University. Prince, KA: PhD Thesis, Faculty of Pharmaceutical Sciences. Advisor: Salgado HRN. Co-advisor: Correa MA, 2008, p. 184. In Portuguese.
22.
Ferreira-NunesRGratieriTGelfusoGM, et al.Mixture design applied in compatibility studies of catechin and lipid compounds. J Pharm Biomed Anal2018; 149: 612–617. Available at: DOI: 10.1016/j.jpba.2017.11.069.
23.
DamstraRJPartschH. Prospective, randomized, controlled trial comparing the effectiveness of adjustable compression Velcro wraps versus inelastic multicomponent compression bandages in the initial treatment of leg lymphedema. J Vasc Surgery Venous Lymphat Disord2013; 1(1): 13–19.
24.
ParkerCNFinlaysonKJShuterP, et al.Risk factors for delayed healing in venous leg ulcers: A review of the literature. Int J Clin Pract2015; 69(9): 967–977.
25.
TaylorRJTaylorADSmythJV. Using an artificial neural network to predict healing times and risk factors for venous leg ulcers. J Wound Care2002; 11(3): 101–105.
26.
MeaumeSCouillietDVinF. Prognostic factors for venous ulcer healing in a non-selected population of ambulatory patients. J Wound Care2005; 14(1): 31–34.
27.
FazliMBjarnsholtTKirketerp-MøllerK, et al.Nonrandom distribution of Pseudomonas aeruginosa and Staphylococcus aureus in chronic wounds. J Clin Microbiol2009; 47(12): 4084–4089.
28.
ForsterAJOakeNRothV, et al.Patient-level factors associated with methicillin-resistant Staphylococcus aureus carriage at hospital admission: a systematic review. Am J Infect Control2013; 41(3): 214–220.
29.
SchmidtchenAWolffHHanssonC. Differential proteinase expression by Pseudomonas aeruginosa derived from chronic leg ulcers. Acta Derm Venereol2001; 81(6): 406–409.
30.
GjødsbølKChristensenJJKarlsmarkT, et al.Multiple bacterial species reside in chronic wounds: a longitudinal study. Int Wound J2006; 3(3): 225–231.
31.
PastarINusbaumAGGilJ, et al.Interactions of methicillin resistant Staphylococcus aureus USA300 and Pseudomonas aeruginosa in polymicrobial wound infection. PLoS One2013; 8(2): e56846.
32.
DeLeonSClintonAFowlerH, et al.Synergistic interactions of Pseudomonas aeruginosa and Staphylococcus aureus in an in vitro wound model. Infect Immun2014; 82(11): 4718–4728.
33.
WellerCDEvansSMStaplesMP, et al.Randomized clinical trial of three-layer tubular bandaging system for venous leg ulcers. Wound Heal Soc [And] Eur Tissue Repair Soc2012; 20(6): 822–829.
34.
BleckenSRVillavicencioJLKaoTC. Comparison of elastic versus nonelastic compression in bilateral venous ulcers: A randomized trial. J Vasc Surg2005; 42(6): 1150–1155.
35.
SilvaFLAraújoJMValleACV, et al.Outdoor treatment of tail necrosis in piglets with ethanol extract of jambolan (Syzygium cumini L. Skeels): Case report. In: Tratamento de necrose de cauda em leitões ao ar livre com extrato etanólico de jamelão (Syzygium cumini L. Skeels): Relato de caso.] XXIV Symposium on Medicinal Plants of Brazil-2016, Belo Horizonte, 21–24 September 2016. In Portuguese.
36.
SinglaRSoniSPatialV, et al.Cytocompatible anti-microbial dressings of syzygium cumini cellulose nanocrystals decorated with silver nanoparticles accelerate acute and diabetic wound healing. Sci Rep2017; 7(1): 10457.
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
