Is Pressurized Irrigation an Effective Alternative to Swabbing for Wound Cleansing?
Condition: Acute and Chronic Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      - 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.
    

Intervention name(s): Pressurized irrigation method; Swabbing wound cleansing method
Intervention type(s): Procedure; Procedure
Intervention description(s): The pressurized irrigation device is modified from using a special Syringe, connected to Gomco's Vacuum/Pressure Pump Model 309 that generate steady irrigation stream at pressure between 4 to 15 psi that is recommended to be safe and effective pressure for wound cleansing.; All patients in control group had wounds cleansed with swabbing technique using forceps and cotton wool (in sterile dressing pack)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pressurized irrigation; wound cleansing method; irrigation; swabbing; appropriate pressure for irrigation