Acute and Chronic Wounds Clinical Trial
Official title:
A Multicenter, Prospective, Randomised Controlled Trial to Compare the Pressurized Irrigation Method With Conventional Practice of Swabbing for Wound Cleansing
The study is to examine the effectiveness of cleansing wound with pressurized irrigation
method compared with conventional practice of swabbing on the wound healing and infection of
acute and chronic wound, and to evaluate the patient's physical symptoms related to wound,
patient's satisfaction to cleansing method, and cost of materials used between the two
groups.
Patients with acute or chronic non-sutured wounds as well as being eligible to exclusion
criteria will be recruited and randomly assigned to be cleansed using either: pressurized
irrigation method (experimental group) or swabbing method (control group).
244 patients will be recruited in the study. This will take place in four community health
centres run by the Hospital Authority in Hong Kong. The wounds of participants will be
cleansed using the assigned method for a six week period. The clinic staff nurse is
responsible for the ongoing assessment of the wound.
Wound assessment will be undertaken at enrolment and upon healing of the wound or at the end
of six-week period if the wounds have not healed. Demographic data and information related
to the wound -wound size +/- wound volume, wound culture swab, and symptoms -wound
discomfort, pain and odour will be collected at enrolment. Information related to the wound
and subjective measures of patient satisfaction -feeling of cleanliness, liking, and of
staff satisfaction -feeling user-friendliness, accessibility, cleanliness, liking to the
cleansing method using VAS will be assessed at completion of treatment. A list of cost
measurements for the wound cleansing would also be captured.
- Registration/ randomization procedure:
Once patients are identified as potential participants at their outpatient clinic visit, the
research nurse will initiate the enrolment process by explaining the objectives of the
proposed study to the patient. Informed consents are obtained for eligible subjects. A
thorough assessment and measurement of the wound will be done by another research nurse.
Participants are asked to complete the first questionnaire. Participants are then randomized
to either intervention or control group. Randomization will be done by a randomization list
generated by a statistician using a simple randomization method and programmed in a
designated computer.
- Schema of intervention delivery and data collection:
The wounds of participants in control group and study group will be cleansed following to
the allocated method until the wounds are completely healed or for six weeks if the wounds
have not yet healed. Wound-care specialists and microbiologists will be consulted throughout
the study for technical advice, particularly on information not readily available in the
literature. Decisions relating to the time period needed to detect wound infection and
healing, as well as the investigations required to detect wound infection, are made in
consultation with this group.
The first research nurse will undertake wound cleansing for experimental group. Wound
cleansing in control group is done as usual by the staff nurses in the four designated
clinics, who will attend an education programme which explains the details of the study, the
procedures to be followed, and the patient documentation. The first research nurse and the
clinic nurse who undertakes dressing change are responsible for the ongoing assessment of
the wound during cleansing and recording the information on the volume of solution and
amount of cleansing materials used, frequency of dressing changes and the type of dressing
applied at each visit. Participants are instructed to report any signs of infection to the
first research nurse and the clinic nurse or physician. The second research nurse who is
blinded to the wound cleansing method will undertake data collection and wound assessment
for all subjects at enrollment and upon healing of the wound or at the end of six-week
period if the wounds have not yet healed. Wounds that have not healed at the end of the
six-week period will be reassessed and data relating to the wound characteristics are
recorded.
- Criteria for study discontinuation:
Participants may be discontinued from the study and assessments at any time. Criteria of
premature withdrawal from trial include 1) Voluntary discontinuation by the participants
without prejudice to further care; 2) Participants lost to follow up. For withdrawal from
trial treatment: 1) Any surgical intervention to the wounds as required; 2) Safety reasons
as judged by investigator; 3) Severe non compliance to the protocol as judged by the
investigator, these patients will be followed to trial completion. Investigators should
document the reasons for withdrawal in patient notes. The decision of withdrawal would not
affect further wound care management.
- Statistical analysis:
The time to wound-healing is analyzed using Cox regression analysis. An intent-to-treat
principle will be applied in the analysis. Patients' time-to-wound-healing are censored at
the time of consent withdrawal, dead or lost to follow up. The difference between the two
arms is assessed using Cox model. Repeated measures ANOVA is performed to compare the
effects of intervention (vs. control) and time (6 week post randomization) on mean wound
size change. The differences in wound symptoms and patient's satisfaction and comfort to
cleansing method are analyzed using Wilcoxon Rank Sum Test. Chi-square test is used to test
difference in the infection incidence and the proportion of wounds completely healed during
follow up between the two groups. Prognostic factors are assessed and adjusted using a Cox
proportional hazard regression model. These variables are: age, body mass index (calculated
from participants' height and weight), wound characteristics (location, types, wound size),
wound status (assessed by Wound Status Assessment score), smoking, presence of underlying
disease, concomitant medication and mental status (assessed by AMT).
- Recruitment schedule:
For the purpose of easy operation and avoiding too many patients accumulated at the same
time, recruitment will be done separately in 10 cycles. The first research nurse need to
perform wound dressing in experimental group for 2 patients per hour, thus 12-13 patients a
day. It will be stopped as soon as 26 patients are recruited in the first week of each cycle
so as to facilitate spreading the attending time of patients in the coming 6-week wound
cleansing visits, therefore they do not need to wait long. That means it takes 2 months to
accomplish recruitment plus 6 weeks wound cleansing and data collection for 24-26 subjects,
therefore 20 months is required for 244 subjects. It is envisaged that the study will take
24 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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