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A Post-Market Randomized Controlled Trial to Evaluate the Efficacy of VELVERT Antimicrobial Wound Dressing Versus Framycetin Cream in Infected Wounds

Author: Aradhana Singh; Anubhav Goyal; Arti Aggrawal; Rajat Kapoor; Deepshika; Vineeta Dhyani
Publisher: Zenodo
DOI: 10.5281/zenodo.17678668
Source: https://zenodo.org/records/17678668/files/MRN-0000084-579588.pdf
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
579
In e na ional Jou nal o Medical
and Pha maceu ical Resea ch
Online ISSN-2958-3683 | P in ISSN-2958-3675
F equency: Bi-Mon hly
A ailable online on: h ps://ijmp .in/
O iginal A icle
A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o
VELVERT An imic obial Wound D essing Ve sus F amyce in C eam in
In ec ed Wounds
A adhana Singh 1, Anubha Goyal 1, A i Agg awal 2, Raja Kapoo 3, Deepshika 4, Vinee a Dhyani 5*
1 Depa men o Su ge y, SN Medical College, Ag a, U a P adesh, India
2 Depa men o Mic obiology, SN Medical College, Ag a, U a P adesh, India
3 Depa men o O hopaedics, SN Medical College, Ag a, U a P adesh, India
4 Depa men o Plas ic Su ge y, SN Medical College, Ag a, U a P adesh, India
5 Depa men o Clinical Resea ch, SN Medical College, Ag a, U a P adesh, India
A B S T R A C T
Co esponding Au ho :
Vinee a Dhyani
Depa men o Clinical Resea ch,
SN Medical College, Ag a, U a
P adesh, India
Recei ed: 15-10-2025
Accep ed: 14-11-2025
A ailable online: 20-11-2025
Backg ound: The p ima y objec i e o his compa a i e s udy was o assess he
e icacy o a new an imic obial wound d essing (VELVERT) agains in ec ed
wound in compa ison o s anda d o ca e (F amyce in c eam). Vel e is a
b ea hable, non-adhe en , and opical wound d essing.
Me hods: Pa ien s wi h in ec ed wound we e assessed and di ided o ecei e
Vel e o s anda d o ca e ea men . Wound assessmen was ca ied ou using
BWAT sco e and bac e ial load assessmen . The clinician’s opinion o he d essing’s
pe o mance was su eyed h ough assessmen o su geon’s ques ionnai e. Pain
le els was e alua ed using a 0-10 Nume ic Pain Cha .
Resul s: On day 24, he VELVERT d essing g oup exhibi ed 58.16% (± 30.15)
educ ion in wound size whe eas, in he s anda d o ca e g oup 55.76 % (± 23.61)
educ ion was obse ed. BWAT sco es ha e gene ally imp o ed (showing lowe
sco es) wound healing. VELVERT was ound o be e ec i e in educing he se e i y
and p e alence o a ious mic oo ganisms. The assessmen o Su geon's
Ques ionnai e esul s showed a posi i e use expe ience.
Conclusion: The d essing was well- ecei ed by pa ien s and esul ed in posi i e
clinician expe ience. VELVERT showed he po en ial o o e ad ancemen s in
wound ca e o pa ien s wi h in ec ed wounds. This is a p omising no el d essing
ha could o e signi ican ad an ages o imp o e he quali y, and con enience o
wound ca e.
Copy igh © In e na ional Jou nal o
Medical and Pha maceu ical Resea ch
Keywo ds: In ec ed wound, wound managemen , an imic obial d essing, he bal
d essing.
INTRODUCTION
A wound is de ined as an inju y o ea on he skin's su ace caused by physical, chemical, mechanical, o he mal damage
(Gha ibi e al., 2015). Wounds a e signi ican con ibu o o mo bidi y and a educed quali y o li e. They also consume a
subs an ial po ion o heal hca e esou ces, om he ini ial inju y o comple e wound healing (Chaby e al., 2007). Wounds
a e classi ied in o wo main ca ego ies based on hei healing p ocesses: acu e and ch onic wounds. Addi ionally, wounds
can be ca ego ized as clean, clean-con amina ed, o con amina ed/in ec ed wounds(Lip ak, 1997; Monaco & Law ence,
2003). In ec ed wounds can lead o a ious complica ions and impede he body's na u al healing p ocesses. An in ec ed
wound occu s when ha m ul mic oo ganisms, such as bac e ia, b each he body's p o ec i e skin ba ie h ough an open
wound. These mic oo ganisms can mul iply apidly, esul ing in localized in lamma ion, o en cha ac e ized by edness,
swelling, wa m h, and pain a he wound si e. In ec ed wound, when no ecei ing adequa e ca e, can esul s in exace ba ion
o he inju y, ampu a ion and sepsis (B em & Tomic-Canic, 2007; Da enpo e al., 2016; Eguia e al., 2019; Ladhani e
al., 2021; Nai e al., 2020). Nume ous con en ional o al and opical medica ions a e a ailable in he ma ke o p e en
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
580
wound con amina ion and p omo e wound healing. These con en ional ea men s include local an isep ic agen s and
an ibio ics. An isep ic agen s encompass hyd ogen pe oxide, chlo hexidine, iclosan, and iodopho s (e.g., po idone
iodine). An ibio ics consis o aminoglycosides (such as F amyce in and Neomycin) and Polymyxin B, Baci acin, among
o he s. While hese emedies p e en wound in ec ion and help main ain wound cleanliness, hey lack wound healing
p ope ies. Fu he mo e, mos o hese emedies ha e side e ec s and d awbacks, including skin i i a ion, ash, and
an ibio ic esis ance (Bu ows, 1958; Do ai, 2012; Lio & Kaye, 2009). The inc ease o an ibio ic esis ance in in ec ed
wounds has led o he need o de elop op ions ha can be used o ea colonized wounds e ec i ely. To manage and
acili a e he healing o in ec ed wounds, di e en d essings ha e been de eloped. These d essings a e designed o c ea e
an op imal en i onmen o wound healing by p omo ing issue epai , p e en ing u he in ec ion, and acili a ing he
emo al o dead issue. Foam-based an imic obial wound d essings can play a c i ical ole in he ea men o in ec ed
wounds. They se e as a ba ie agains ex e nal con aminan s; help main ain a mois en i onmen ha suppo s he healing
p ocess and can elease an imic obial agen s o comba in ec ion.
VELVERT, an an imic obial d essing manu ac u ed by Da Medip oduc s P i a e Limi ed, is indica ed o use in Diabe ic
Foo Ulce s (DFUs), auma, in ec ed wounds, and bu n wounds, among o he s. I is a non-adhe en opical wound d essing
loaded wi h an an imic obial o mula ion o F-10 (ex ac s om Cu cuma longa, Phyllan hus emblica, and Camellia
sinensis) on a polyme ic sponge made om biopolyme s (gela in and chi osan). The d essing is highly po ous, acili a ing
exuda e abso p ion om wounds. The unique an imic obial o mula ion comba s in ec ions wi hin he wound, aiding he
healing p ocess. Fu he mo e, he d essing is biocompa ible and biodeg adable. VELVERT has p e iously demons a ed
e ec i e ea men ou comes in enous leg ulce s (VLUs) and shows p omise in b oade wound ca e applica ions (Kuma
e al., 2024).
The p esen s udy majo ly aims o compa e he e icacy o VERLVERT wi h amyce in. The p ima y objec i es o he
cu en s udy a e: 1) To assess he e icacy o a new an imic obial wound d essing (VELVERT) compa ed o amyce in
in in ec ed wound wi h espec o healing a es based on clinical e alua ion and e alua ion o wound pho og aphs, 2) To
assess he mic obial load in wounds. The seconda y objec i es included: 1) Assessmen o sa e y based on ad e se e en s
and incidences o wound complica ions like in ec ion associa ed wi h he use o d essings (VELVERT and S anda d o
ca e) in in ec ed wound, 2) Assessmen o d essings in in ec ed wound by In es iga o s based on su geon’s ques ionnai e,
3) Assessmen o VELVERT e icacy based on educ ion in subjec ’s pain le els.
Ma e ial and me hods
S udy design and Pa icipan s
This s udy was a p ospec i e, single cen e , wo a m, andomized open label, pos ma ke su eillance s udy on in ec ed
wound. 50 pa ien s wi h in ec ed wounds we e sc eened o he s udy and hen andomized in o wo g oups: he s anda d
g oup, ecei ing he S anda d o ca e wi h F amyce in c eam and he es g oup, ecei ing Vel e d essing. No changes o
he clinical in es iga ion plan we e made du ing ial, s udy was pe o med as pe app o ed p o ocol. Elec onic Da a
Cap u e (EDC) was used in s udy.
Pa ien en olmen in he s udy occu ed ollowing he eceip o e hical app o al om he ins i u ional e hics commi ee
(Ins i u ional E hics Commi ee, EC egis a ion Numbe : ECR/1409/Ins /UP/2020, In es iga ional Si e: S.N Medical
College, Ag a, India) and CTRI egis a ion (CTRI/2022/05/042407). Subjec con iden iali y was main ained h oughou
he s udy while ob aining da a. The s udy was conduc ed a e mee ing all he local e hical equi emen s and was in
acco dance wi h In e na ional Con e ence on Ha moniza ion Guideline-Good Clinical P ac ice E6 (ICH-GCP), he
Decla a ion o Helsinki, ISO 14155:2020 and applicable egula o y equi emen s.
A e e alua ing he eligibili y c i e ia, pa ien s wi h in ec ed auma ic and pos -su ge y wounds we e en olled in he s udy
a e ge ing w i en consen and andomised using an In e ac i e Web Response Sys em (IWRS) o one o wo a ms. The
maximum du a ion o each pa icipan in he cu en s udy was 24 days a e i s d essing applica ion (ei he S anda d o
Vel e D essing) including all isi s. All po en ial pa ien s wi h in ec ed wound o bo h gende s be ween 18-70 yea s o
age, and pa ien s o all socio-economic s a us who me he s udy ela ed inclusion and none o he exclusion c i e ia we e
en olled in he s udy (Table 1). Demog aphic cha ac e is ics o he s udy pa icipan s a e de ined in Table 2. Sample size
was calcula ed as de ined p e iously (Schmiedo a e al., 2024), wi h 0.05 p obabili y o ype I e o , 80% powe and 10
pe cen an icipa ed d op-ou a e. None o he pa icipan s, esiden su geons, and ou come assesso s we e blinded o he
in e en ions.
Ou come
The s udy pe iod in ol ed a o al o 8 isi s o VELVERT (d essing was changed e e y 4 h day) and 14 isi s o s anda d
o ca e (changed e e y al e na i e day). Sc eening, in o med consen , and baseline da a was collec ed on isi 1. The
p ima y endpoin o he s udy was he incidence o wound healing s a us wi h 50% o mo e co e age in up- o 24 days. The
wound a ea was measu ed by calcula ing he leng h (longes pa o he wound) and wid h (wides pa o he wound) o
he wound using a s e ilize, single-use pape ule . Pho og aphs o wound we e aken be o e and a e he applica ion o
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
581
he in es iga ional VELVERT on day 0, 8, 20, and day 24. The second p ima y endpoin was compa a i e e alua ion o
wounds h ough BWAT in e ms o wound size, dep h, edges, loca ion, unde mining, nec o ic issue, exuda e ype and
amoun , skin colo a ound he wound, pe iphe al issue edema and indu a ion, g anula ion, epi helializa ion. P incipal
in es iga o assessed he wounds h oughou he ial. The hi d p ima y endpoin was bac e ial load assessmen , ca ied
ou h ough cul u es om swab es on day 0 and day 24 o upon de ice emo al due o wound closu e. The cul u e pla es
a e examined ho oughly and he a ious colony mo pho ypes p esen a e iden i ied. Cul u e load was e alua ed in semi-
quan i a i e way wi h g ading o mic oo ganisms’ p esence in wounds as scan y, mild, mode a e o hea y. Mild g ow h
was de ined as he p esence o g ow h only on he p ima y quad an /s eak, mode a e g ow h as p esence o g ow h up o
he second quad an /s eak and se e e as p esence o g ow h on e ia y quad an /s eak.
Seconda y endpoin was e alua ion o sa e y by moni o ing ad e se e en s and inciden s o wound complica ions. Ano he
seconda y endpoin was clinician’s opinion o he d essing’s pe o mance was su eyed h ough assessmen o su geon’s
ques ionnai e. The ques ions we e posed on a i e-poin Like scale in ela ion o he ease o handling, app op ia eness o
ins uc ion o use, ease o applica ion, con o mance o issue su aces and o e all pe o mance o de ice. On his scale o
one o i e, 1 ep esen s "Easy" and 5 ep esen s "Di icul " ela ed o expe ience du ing use o de ices. The hi d seconda y
endpoin was sys ema ic e alua ion o pain elie du ing each pa ien isi using a 0-10 Nume ic Pain Cha , wi h he
nume ical scale anging om 0 (indica ing no pain) o 10 ( ep esen ing he wo s pain imaginable).
S a is ical Analysis
Ca ego ical da a was p esen ed as equencies and a ios (%) and as means o con inuous da a. All s a is ical es s we e
pe o med using R So wa e, Ve sion 4.3.0. Be ween g oup p- alues a e based on wo-sample - es .
Resul s
P ima y Ou come
The low o pa ien s du ing en ollmen , alloca ion, ollow-up, and analysis is shown in Figu e 1 as pe he CONSORT
p o ocol. All pa icipan s we e ollowed o a pe iod o 24 days a e en ollmen . P ima y ou comes shows whe he
VELVERT ea men esul s in achie ing wound healing s a us o 50% o mo e wound co e age in up- o 24 days (Figu e
2), compa a i e e alua ion o wounds h ough BWAT sco e, and compa a i e e alua ion o wound in ec ion. The ou comes
show ha by Day 24, he VELVERT d essing g oup demons a ed a compa able educ ion in wound size 58.16 % (±
30.15%) o ha o he s anda d o ca e g oup 55.76 % (± 23.61). No ably, du ing he ea ly ea men phase (Day 0 o Day
8), he VELVERT d essing g oup exhibi ed a g ea e educ ion in wound su ace a ea 24.74 % (± 17.48) compa ed o he
s anda d o ca e g oup 19.56 % (± 26.07) (Figu e 3 and 4). While he di e ences a e no subs an ial, hey suppo he
e ec i eness o bo h d essings in p omo ing wound healing. A he end o he ea men (day 24), 13 pa ien s in bo h he
g oup showed 50% o mo e wound healing. Howe e , among hese pa ien s, 9 (40.09%) pa ien s achie ed 75% o mo e
wound closu e in VELVERT g oup whe eas in con ol g oup only 4 pa ien s (18.18%) achie ed his alue, including 2
pa ien s wi h comple e wound closu e in bo h he g oup.
Seconda y Ou come
The wounds o each en olled pa ien we e also assessed using BWAT sco e (Figu e 5). The BWAT sco e is a sys ema ic
ool used o assess wounds, and i in ol es he conside a ion o 15 di e en pa ame e s (men ioned ea lie ). Ou o hese
15 pa ame e s, 13 a e sco ed i ems, and 2 a e non-sco ed i ems. Each o hese pa ame e s was assessed on a modi ied Like
scale, anging om 1 o 5. On his scale, a sco e o 1 indica es he leas se e e o a ou able condi ion, while a sco e o 5
indica es he mos se e e o un a ou able condi ion o he speci ic wound cha ac e is ic being assessed. The BWAT sco es
ha e gene ally imp o ed (showing lowe sco es) indica ing g adual wound healing (Figu e 5). No able imp o emen was
seen in he 21-25 sco e ange o VELVERT g oup, whe e numbe o pa ien s inc eased om 0 o 9 (a aining a lowe
sco e om highe sco e) (Figu e 5). On he comple ion o ea men , a ound 86.36 % pa ien s a ained a sco e wi hin he
ange o 21-25 o less, whe eas, in he s anda d o ca e g oup, 72.72% a ained hese sco es (Figu e 5). Mo eo e ,
app oxima ely 9% o pa ien s om con ol g oup showed a highe BWAT sco e (36-40 ca ego y), howe e no pa ien om
VELVERT g oup had shown his BWAT sco e a he end o he s udy. Ano he p ima y ou come assessed was p esence o
in ec ion a he wound si e (Figu e 6). Each pa ien unde wen a comp ehensi e and me iculous e alua ion o hei wound
cul u es o assess he in ec ion. On day 0, di e en s ains o mic oo ganisms we e ound in all he en olled pa ien s in bo h
he g oups (Figu e 6). On Day 24, he da a demons a es e ec i eness o VELVERT in mi iga ing he p esence o
Klebsiella pneumoniae ac oss all se e i y ca ego ies, as compa ed o he s anda d o ca e. In VELVERT g oup, no inc ease
in in ec ion in any ca ego y was obse ed, howe e , in F amyce in g oup in ec ion was obse ed on Day-24 ha was no
p esen ini ially. Mo eo e , VELVERT comple ely educed he Klebsiella pneumoniae in pa ien s wi h hea y le els.
VELVERT also exhibi ed e icacy agains S aphylococcus au eus in ec ions, pa icula ly in p e en ing hei hea y
p oli e a ion. These indings collec i ely sugges ha VELVERT is e ec i e in educing he se e i y and p e alence o
a ious mic oo ganisms in in ec ion wounds. Seconda y ou comes show he o e all pe o mance o he p oduc in e ms
o ease o handling and applica ion, and con o mance o he issues based on su geon’s ques ionnai e, ad e se e en s
moni o ing and pa ien com o in e ms o pain educ ion. The e icacy o VELVERT was assessed based on he educ ion
in subjec s' pain le els. Compa a i e e alua ion o pa ien s’ eco ding hei pain le el on a scale o 0- 10 Nume ic Pain
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
582
Cha on day o d essing and i s inal emo al (0=no pain, 10=wo s pain imaginable) was done. A he baseline, bo h
g oups exhibi ed high pain le els, he ea e , he e was a g adual dec ease in bo h he g oup. Pain alle ia ion om se e e
o mode a e (de ined as 5 on he scale) was achie ed ollowing 3 applica ions o VELVERT d essing, while same educ ion
in pain was achie ed wi h 5 applica ions o s anda d o ca e. On day 24, he mean change in pain le els om he baseline
o he VELVERT d essing g oup is -5.77 (± 1.78), while he S anda d o ca e g oup shows a mean change o -5.64 (±
1.92) (Table 3). Su geon's Ques ionnai e was used o e alua e da a on a ious cha ac e is ics ela ed o he pe o mance
and use expe ience o VELVERT d essing. The da a indica es a consis en ly posi i e use expe ience, wi h use s inding
he de ice easy o handle, app op ia e in e ms o ins uc ions, easy o apply, and e ec i e in con o ming o issue su aces
(Table 4, da a is shown only o ini ial and las applica ion o he d essings). O e all, i was obse ed ha VELVERT
d essing gene ally pe o med sligh ly be e han s anda d o ca e. No ably, VELVERT seems o ha e a sligh ad an age
in con o mance o issue su aces on Day 24. Two ad e se e en s headache and emesis, bo h we e mode a e in na u e, was
obse ed in he s anda d g oup, which eco e ed by nex day.
Figu e 1: S udy low cha .
Figu e 2: Pic o ial ep esen a ion o applica ion o Vel e d essing on wound si e.
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
583
Figu e 3: Pe cen age educ ion in wound su ace a ea wi h espec o ime.
Figu e 4: Clinical ep esen a ion on he i s and las day o isi : (A) VELVERT d essing and (B) F amyce in (S anda d
o ca e).

A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
584
Figu e 5: BWAT Sco e: A compa ison be ween he sco e a he s a o he s udy (A) and a end o he s udy o las day
o d essing (B) s numbe pa ien s alling in a pa icula ange o sco e.
Figu e 6: Mic o-o ganism ound in swab sample collec ed o cul u e om pa ien s wi h in ec ed wound: F amyce in
g oup (A-D) and VELVERT (E-H). Pe cen age o pa ien s showing changes in mic oo ganism p o ile om baseline.
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
585
Table 1: Summa izes he c i e ia used o de e mine eligibili y o pa icipa ion in he s udy. Inclusion c i e ia speci y he
cha ac e is ics equi ed o en ollmen , while exclusion c i e ia indica e condi ions o ac o s ha disquali y po en ial
pa icipan s
Inclusion c i e ia
1. Pa ien s we e equi ed o ha e he abili y o ead and comp ehend he in o med consen documen and sign i
o p o ide da a o he s udy.
2. Pa ien s had o consen o he collec ion o hei da a a p ede ined ollow-up in e als.
3. Female subjec s we e eligible i hey we e willing o use con acep i e pills o he s udy, we e pe manen ly
s e ilized, o me he c i e ia o pos -menopause, de ined as he cessa ion o menses o a leas wel e (12)
mon hs p io o en ollmen .
4. Pa ien s had a his o y o su e ing om in ec ed wounds wi h a size o mo e han 25 cm2.
5. Pa ien s had auma ic in ec ed wounds wi h a du a ion o less han 1 mon h.
Exclusion c i e ia
1. Pa ien s who we e unwilling o unable o comply wi h he necessa y ollow-up isi s o da a collec ion.
2. Pa ien s who es ed posi i e o HIV, HBsAg, and HCV.
3. Concu en pa icipa ion in ano he clinical ial.
4. P egnan emales.
5. Pa ien s on immunosupp essi e medica ion, co icos e oids, o unde going chemo he apy.
6. Pa ien s wi h impai ed decision-making capaci y.
7. Pa ien s wi h a se e e como bid diso de , no expec ed o su i e mo e han 12 mon hs.
8. Those wi h ac i e diabe ic oo in ec ions.
9. Pa ien s wi h alle gies o any ma e ials con ained in in es iga ional de ices.
10. Pa ien s wi h speci ic wound ypes, such as bu n wounds, DFU, malignan ulce s, ube cula ulce s, lep o ic
ulce s, gang enous ulce s, ischemic ulce s, o bed so es.
11. Any o he condi ion ha , acco ding o he in es iga o 's judgmen , could in e e e wi h he s udy.
Table 2: Demog aphic cha ac e is ics o he s udy pa icipan s. Da a is p esen ed as mean ± S.D. o pe cen age.
Cha ac e is ics
S anda d o ca e
(N=25)
VELVERT D essing
(N=25)
Age (Yea s)
38.92 ± 14.93
37.80 ± 14.26
BMI (kg/m2)
24.24 ± 1.67
24.56 ± 1.91
Heigh (cm)
166.96 ± 4.47
165.32 ± 5.71
Weigh (kg)
67.56 ± 5.19
67.08 ± 5.50
Gende n (%)
Male
24 (96.0)
22 (88.0)
Female
1 (4.0)
3 (12.0)
Smoke n (%)
Yes
0 (0.0)
0 (0.0)
No
25(100.0)
25(100.0)
Table 3: Pain le els om he baseline o he VELVERT and s anda d o ca e.
Pain
F amyce in
VELVERT D essing
p alue
Day 4
-1.16 ± 0.83
-1.00 ± 0.69
0.081
Day 8
-2.32 ± 1.39
-2.26 ± 1.03
0.077
Day 12
-3.09 ± 1.28
-2.96 ± 1.12
0.747
Day 16
-3.71 ± 1.40
-3.65 ± 1.37
0.706
Day 20
-4.68 ± 1.77
-4.74 ± 1.54
0.413
Day 24
-5.64 ± 1.92
-5.77 ± 1.78
0.307
Table 4: Assessmen o d essings based on su geon's ques ionnai e ega ding hei expe ience wi h use o d essing o he
ea men o in ec ed wound. The da a is analysed based on a ious pa ame e s on a scale o 1 o 5, whe e 1 ep esen s
"Easy" and 5 ep esen s "Di icul " ela ed o expe ience du ing use o de ices.
Cha ac e is ics
Le els
S anda d o ca e
VELVERT D essing
Day 0
Day 24
Day 0
Day 24
Ease o handling
1
22 (88%)
20
24 (96%)
22 (100%)
2
1 (4%)
1
1 (4%)
0 (0%)
3
1 (4%)
0 (0%)
0 (0%)
0 (0%)
4
1 (4%)
0 (0%)
0 (0%)
0 (0%)
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
586
App op ia eness o
ins uc ion o use
1
21 (84%)
20 (95%)
24 (96%)
20 (91%)
2
4 (16%)
0 (0%)
1 (4%)
2 (9%)
3
0 (0%)
1 (5%)
0 (0%)
0 (0%)
Ease o applica ion
1
20 (80%)
20 (95%)
23 (92%)
21 (95%)
2
4 (16%)
0 (0%)
2 (8%)
1 (5%)
3
1 (4%)
1 (5%)
0 (0%)
0 (0%)
Con o mance o issue
su ace
1
16 (64%)
14 (67%)
16 (64%)
18 (82%)
2
8 (32%)
7 (33%)
9 (36%)
4 (18%)
4
1 (4%)
0 (0%)
0 (0%)
0 (0%)
O e all pe o mance o
de ice esponse
1
16 (64%)
16 (76%)
21 (84%)
22 (100%)
2
9 (36%)
5 (24%)
4 (16%)
0 (0%)
Discussion
Wound healing can be impai ed by he p esence o in ec ion; mic oo ganisms om di e en sou ces a e p esen ed wi h an
oppo uni y o colonize, no ably in he case o ch onic wounds. Bac e ia a e a common pa o he skin mic obio a and
wounds, howe e eaching abo e a c i ical h eshold o exis ing bac e ia and he de elopmen o a bio ilm may impede
wound healing p ocess (Bowle e al., 2001). The inc ease o an ibio ic esis ance in in ec ed wounds has led o he need
o de elop u he op ions which can be used o ea in ec ed wounds e ec i ely. The cu en clinical s udy was conduc ed
o e alua e he sa e y and e icacy o an he bal an imic obial d essing VELVERT agains in ec ed wounds in compa ison
o s anda d ea men wi h F amyce in c eam. Healing p og ession was measu ed by obse ing he educ ion in he wound
a ea and sco ing he condi ion o he wound by moni o ing changes in 15 di e en pa ame e s as a cumula i e BWAT
sco e. A he end o he s udy, 2 pa ien s achie ed comple e closu e o he wound and in ac su ace was obse ed. 7 pa ien s
achie ed 75% o < 100% wound co e age wi h >0.5cm epi helial issue ex ension in o he wound bed. Fo emaining 13
pa ien s, less han 75% wound closu e was obse ed, whe eas in p e ious s udies hey epo ed healing a e o 47.5% o
Alle yn and 50.7% o Mepilex (F anks e al., 2007). Majo i y o wounds a e polymic obial, in ha , hey in ol ing bo h
ae obic and anae obic mic oo ganisms (Twum-Danso e al., 1992). An an imic obial d essing, hus, should be e ec i e
agains bo h ae obic and anae obic mic oo ganisms. S. au eus is conside ed one o he mos p oblema ic bac e ium in
wound in ec ions(Bowle e al., 2001; Roy e al., 2020; Ru he o d & Spence, 1980; Twum-Danso e al., 1992). In he
p esen s udy, VELVERT was ound o be e ec i e in dec easing he S. au eus load om 32% (including 20% hea y load)
o 5%, in addi ion o o he mic oo ganisms. VELVERT was able o e ec i ely educe he se e i y and p e alence o
a ious mic oo ganisms in in ec ion wounds when compa ed o he s anda d o ca e. Ano he clinically impo an ac o o
conside is he le el o exuda e while e alua ing an an imic obial d essing. In ec ed wounds o en p oduce excessi e
exuda e ( luid) con aining in ec ious ma e ial. VELVERT is designed o high exuda e abso p ion. Adequa e abso p ion
o exuda e dec eases wound size and aids in healing p ocess (Alihosseini e al., 2023). One o he pa ame e in BWAT
sco e is he exuda e amoun which was e alua ed using a sco ing sys em anging om 1-5, whe e 1 ep esen s he d y
issue wound and 2-5 ep esen s a ying deg ee o exuda e. By he end o he s udy mean sco e o VELVERT was ound
o be 1.27 ± 1.39 and o s anda d o ca e i was 1.23 ± 1.13. Howe e , he numbe o VELVERT d essing used was
app oxima ely hal o ha o s anda d o ca e, since, s anda d o ca e was changed e e y al e na i e day and VELVERT
d essing was changed e e y 4 h day. In ou s udy, VELVERT’s con o mabili y was ound o be e ec i e along wi h
s anda d o ca e, which exp esses he p oximi y o d essing wi h he wound bed (Lus ig & Ge en, 2021). A supe io
con o mance o issue educes he po en ial exuda e pooling be ween wound and d essing gaps, (Lus ig & Ge en, 2021) as
was obse ed wi h VELVERT. D essing changes cause mode a e o se e e pain in 74% o pa ien s and causes subs an ial
s ess o pa ien s and clinicians (Ga dne e al., 2014). Pain expe ienced du ing d essing changes is compa able o
mo emen -e oked pain, as bo h in ol e mechanical s imula ion a he wound si e, which can igge o in ensi y pain
(Ga dne e al., 2017). In addi ion o dec eased numbe o d essing changed, he non-adhe en p ope y o his d essing is
ad an ageous in he managemen o pain du ing wound ca e p ocess. In he cu en s udy, he pain le el was educed om
se e e o mode a e le el ollowing 4 h isi in compa ison o s anda d o ca e, whe e same le el o pain decline was achie ed
a e 7 h isi . A he end o he s udy, a p ominen dec ease in he le el o pain was obse ed wi h lesse isi s in compa ison
o s anda d o ca e. Fu he s udies and clinical ials ocused on an imic obial d essings can shed ligh on hei espec i e
bene i s and guide medical p o essionals in making in o med decisions ega ding he managemen o in ec ed wounds.
Mul i-modal app oaches o wound managemen , in ol ing physical deb idemen and an imic obial he apy has been shown
o enhance healing. An imic obial d essings ha a e able o in e e e wi h bio ilms exis ing in ha d- o-heal wounds can
po en ially aid wound ca e p ocess. In he cu en s udy, VELVERT D essing was mo e e ec i e in mi iga ing he p esence
o Klebsiella pneumoniae ac oss all se e i y ca ego ies compa ed o he S anda d o ca e. Addi ionally, ini ially wo mo e
pa ien s had S. au eus in ec ion ha we e included in he VELVERT g oup, howe e , one pa ien in each g oup was ound
o be in ec ed wi h a hea y load o S aphylococcus au eus on he las day o he s udy.
A adhana Singh e al. A Pos -Ma ke Randomized Con olled T ial o E alua e he E icacy o VELVERT An imic obial
Wound D essing Ve sus F amyce in C eam in In ec ed Wounds. In . J Med. Pha m. Res., 6 (6): 579‐588, 2025
587
Conclusion
In conclusion, VELVERT d essing demons a es p omising po en ial as an ad anced wound ca e solu ion. I s abili y o
enhance p o ec ion agains in ec ions, p omo e as e wound closu e, and imp o e pa ien com o by educing d essing
changes and managing exuda e e ec i ely makes i a aluable op ion o ea ing in ec ed wounds. Fu he mo e, he
absence o ad e se e en s in he VELVERT g oup highligh s i s sa e y p o ile. These indings sugges ha VELVERT
could signi ican ly enhance he quali y and con enience o wound ca e, o e ing a no el and e ec i e al e na i e o
s anda d o ca es.
Acknowledgemen s: We hank SNMC depa men o Su ge y and depa men o O hopaedics o conduc ion o his
s udy.
Au ho Con i ma ion: All au ho s e iewed he manusc ip and app o ed he inal e sion o he manusc ip .
Au ho Disclosu e : The au ho s epo no con lic s o in e es in his wo k. This a icle was w i en by he au ho s lis ed.
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