PMID- 34554831
OWN - NLM
STAT- MEDLINE
DCOM- 20210927
LR  - 20220426
IS  - 0969-0700 (Print)
IS  - 0969-0700 (Linking)
VI  - 30
IP  - 9
DP  - 2021 Sep 2
TI  - Management of hard-to-heal leg ulcers with an acid-oxidising solution versus 
      standard of care: the MACAN study.
PG  - 694-704
LID - 10.12968/jowc.2021.30.9.694 [doi]
AB  - OBJECTIVE: The efficacy of available wound dressings in the treatment of 
      hard-to-heal wounds is limited. A new therapeutic approach using an 
      acid-oxidising solution (AOS) was developed. Its effect on healing progress, 
      tolerability and safety properties were investigated in a clinical study, and 
      compared with standard of care (SOC) wound dressings. The study aimed to 
      demonstrate the non-inferiority of AOS to SOC in terms of wound healing progress. 
      METHOD: This open-label, randomised controlled trial was conducted at two study 
      centres in Austria with patients with either infected or non-infected 
      hard-to-heal leg ulcers of different aetiology. Patients were treated for six 
      weeks either with AOS or SOC wound dressings. Outcome assessments included the 
      percentage of granulation and re-epithelialisation tissue, wound size reduction, 
      changes in wound pH, infection control and wound pain, local tolerability and 
      adverse events (AEs). Healing time and rate were also assessed. RESULTS: A total 
      of 50 patients took part. In the AOS group, wounds exhibited higher amounts of 
      granulation and re-epithelialisation tissue, and a faster and more pronounced 
      wound size reduction compared with wounds in the SOC group. In the AOS-treated 
      versus SOC-treated patients, a greater percentage of complete healing of 
      hard-to-heal ulcers was achieved by the end of the study period (32% versus 8%, 
      respectively). Furthermore, the wound pH decreased significantly faster in these 
      wounds (p<0.0001). In all patients with infected leg ulcers, local infection was 
      overcome more rapidly under AOS treatment. In the AOS group, one AE and no 
      serious adverse events (SAEs) were detected versus 24 AEs and two SAEs in the SOC 
      group. CONCLUSION: In this study, AOS proved to be a highly effective treatment 
      to support wound healing in infected or non-infected hard-to-heal leg ulcers of 
      different aetiology. Efficacy was found to be not only non-inferior but superior 
      to SOC wound dressings. Furthermore, tolerability and safety profiles were 
      favourable for AOS.
FAU - Strohal, Robert
AU  - Strohal R
AD  - Department of Dermatology, Federal Academic Teaching Hospital of Feldkirch, 
      Austria.
FAU - Mittlbock, Martina
AU  - Mittlbock M
AD  - Center for Medical Statistics, Informatics, and Intelligent Systems, Medical 
      University of Vienna, Austria.
FAU - Muller, Werner
AU  - Muller W
AD  - Central Ambulance of Wound Care, Department of Nursing, Federal County Hospital 
      of Bregenz, Austria.
FAU - Hammerle, Gilbert
AU  - Hammerle G
AD  - Central Ambulance of Wound Care, Department of Nursing, Federal County Hospital 
      of Bregenz, Austria.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - J Wound Care
JT  - Journal of wound care
JID - 9417080
MH  - Bandages
MH  - Humans
MH  - *Leg Ulcer/therapy
MH  - *Standard of Care
MH  - Treatment Outcome
MH  - Wound Healing
OTO - NOTNLM
OT  - AOS
OT  - DFU
OT  - Nexodyn
OT  - SOC
OT  - acid-oxidising solution
OT  - adverse events
OT  - chronic
OT  - diabetes
OT  - diabetic
OT  - dressing
OT  - dressings
OT  - foot ulcers
OT  - hard-to-heal
OT  - healing
OT  - leg ulcers
OT  - standard of care
OT  - tolerability
OT  - ulcers
OT  - wound
OT  - wound care
OT  - wound dressing
OT  - wound healing
OT  - wound microenvironment
EDAT- 2021/09/24 06:00
MHDA- 2021/09/28 06:00
CRDT- 2021/09/23 17:14
PHST- 2021/09/23 17:14 [entrez]
PHST- 2021/09/24 06:00 [pubmed]
PHST- 2021/09/28 06:00 [medline]
AID - 10.12968/jowc.2021.30.9.694 [doi]
PST - ppublish
SO  - J Wound Care. 2021 Sep 2;30(9):694-704. doi: 10.12968/jowc.2021.30.9.694.