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EWMA 2013 - Ep486 - Efficacy trials on the use of a new dressing for the healing of cuts and grazes a randomised and controlled trial
1. THE USE OF A NEW DRESSING FOR THE HEALING OF
CUTS AND GRAZES:
A RANDOMIZED AND CONTROLLED TRIAL
Tommaso Bianchi*,
Angela Peghetti°, Elisabetta Ghelli*
*Dermatology Unit, Bellaria Hospital, Bologna, Italy
°Evidence-based Nursing Unit, S. Orsola Hospital, Bologna, Italy
2. background
• A large amount of surgical procedures, mainly removal of simple skin lesions, are
expleted in outpatient setting.
• Treatment of outpatient post-operative surgical wounds is a worldwide,
cost-consuming challenge for a variety of medical specialties.
• Because of low price and simplicity, gauzes have been used for centuries in
treatment of surgical wounds, basing on the rationale of exudate absorbption and
avoidance of infections. These dressings require high frequency of changes and do
not consent simple daily-life procedures such as showering.
• Moist environment wound repair occlusive dressings prevent eschar formation
and protect against bacteria, require less frequency of change and permit the
patients to properly shower reducing procedure discomfort.
Lee CK, Hansen SL.Management of acute wounds.Surg Clin North Am. 2009 Jun;89(3):659-76.
3. setting / patients
• All adult patients admitted to the Dermatologic Surgery outpatient of the Bellaria Hospital, Bologna, Italy
who had a surgical wound have been enrolled.
• Inclusion criteria:
– Area < 80 square centimeters
– Age > 18
• Exclusion criteria:
– Pregnancy
– Age < 18
– Treatment with systemic steroids, radiotherapy or chemoterapy
– Suspected or confirmed allergy to dressing components
– Infection/inflammation at wound site
– Patients enrolled before 10 days to the same study
– Patients with life expectancy of less than 6 months
– Wounds treated with vacuum-assisted closure devices, ostomies or drain openings, and pin holes
from external fracture fixation materials
• Patients were randomized for either occlusive or gauze-based local wound care by means of a computer
randomization program, which ensured allocation concealment.
4. procedures
t7 t14t1
Traditional Gauze
Stericompress
Occlusive
MySkin
cut & grazes
- Patients randomized to gauze group were istructed to change dressing daily.
- Patients randomized to occlusive group were istructed to change dressing every
3 days at t4, t7, t10, t13.
- Patients were scored with Bates-Jansen Wound Assessment Tool (BWAT) at t1,
t7, t14
- Patients were scored for pain during change and pain during interval time from
changes using Numeric Pain Intensity Scale at t1, t7, t14
- Local cleansing was permitted only with saline solution for both groups
5. outcome assessment
• Primary outcome parameter:
wound healing obtained by Bates-Jensen
wound assessment tool (13 items, score
13-60)
• Secondary outcome parameter:
pain during change and pain during
interval time from changes using Numeric
Pain Intensity Scale (0-10)
• Statistical analysis of data was made by
two tails student t- test
Size
Depth
Edges
Undermining
Necrotic tissue type
Necrotic tissue amount
Exudate type
Exudate amount
Perilesional skin colour
Peripheral tissue edema
Peripheral tissue induration
Granulation tissue
Epitelialization
6. Results
• ITT 150 patients
• 123 Total patients enrolled and analyzed:
• 61 males, 62 Females, age 14-92 (59)
• 65 randomized to occlusive dressing
• 58 randomized to traditional dressing
7. Results
Statistical analysis found significance:
• Primary outcome at 7 days (BWAT score)
p < 0.05 (mean 14.17 vs 15.51)
• No significantly difference was found in pain at
changes and from change to change and in BWAT
score at 14 days.
• Two cases of ACD associated with occlusion dressing
(higher concentration of acrylate compounds)
8. Discussion
Selection of moist wound enviroment versus traditional dressing is still a
controversial topic.
This trial led us to think that, albeit in a dermatological surgical setting, the use
of moist wound environment dressings such as MySKIN for closure of surgical
wounds is associated with better reepithelization at 7 days after surgical
procedure.
Even if Quality of Life was not taken in account as one of the main parameters
of the study, 74% of patients belonging to occlusion (MySKIN) group would
reccommend use of their dressing versus 42% of patient belonging to
traditional (Stericompress gauze) group.