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					                ‘Can Sutures Get Wet?’                  Introductions

      Clare Heal, Petra Buttner, Bev Raasch, Sheldon    0.5 Senior Lecturer Mackay
    Browning, David Graham, Margaret Campbell, Robert
               Cruikshank, Rachel Bidgood
                                                        2004 Mackay Rural Clinical
                                                        School JCU

                                                        Mackay’s population: 75,000

                                                        No doctors – please come!

GP & PHC Conference, Perth, 6 July 2006

 ‘Can Sutures Get Wet?’                                 History of Project
 A prospective randomised controlled trial of wound
 management in general practice                          Monthly GP EBM meeting – very active group

                                                         Considering ‘group’ research project for some time
     Background -how project conceived
                                                         Discussed several potential projects - brainstorming
                                                         ‘Does wetting sutures increase the risk of infection?’

     Process, reflections on GP research group           Patients like to shower in Mackay – is that ok?

                                                         Pilot program undertaken in one practice


                                                         ‘Standard advice’ keep wound dry and covered for
                                                         48hrs. Most practices delivered this advice

                                                         Paucity of literature relating to this subject- most
                                                         data indicates no difference if wound wet or

                                                         Pilot study 543 patients, no difference in incidence
                                                         of infection for wet or dry.

Clinical Question                                   Design

  Can patients uncover and wet stitches in the       Prospective Randomized Control Trial
  first 48hrs after minor skin procedures without
  increasing the incidence of infection?

Participants and Recruitment

  19 GPs from 4 different practices

  Data collection Oct 2004 - May 2005

  Consecutive patients presenting for minor
  skin excision

  Practice nurse responsible for recruitment &
  data collection

Eligibility Criteria                                Surgical wound management protocol

Inclusion                Exclusion                   Skin prep normal saline
  Minor skin excision      Face
                                                     Sterile technique – sterile gloves
  Diabetes, anaemia,       Oral/topical Abs
  PVD (recorded)           Immunosuppressants        Suture material – nylon
                           Flap/two layer
                           Lacerations               No antibiotics / topical antiseptics
                           Sebaceous cyst
                                                     Dressing – melolin and tape

                                                     ROS – back 10 days, other sites 7 days

    Intervention                                                                                                Clinical Outcome
                                            Wound Management                                                           CDC definition of superficial surgical site
                                                                                                                       infection – standardised surveillance criteria:
                                                                                                                       1. Infection within 30 days
                          Wet                                                   Dry
                                                                                                                       2. a. Purulent discharge from wound or
          Take dressing off within first 12 hrs                     Keep dressing on for 48hrs
                                                                    Keep wound dry for 48hrs                               b. Doctor diagnoses infection or
        Bathe as normal until sutures taken out           After 48hrs take dressing off and bathe as usual
                                                                                                                           c. Doctor commences antibiotics
               Avoid use of antiseptics                             Avoid the use of antiseptics
                                                                                                                        3. Stitch abscess doesn’t count as infection

                                                                                                                       Rather vague – but ‘Gold standard’

    Sample Size                                                                                                 Randomisation

        Consulted biostatistician                                                                                Picking balls out of a bag
        Based on pilot study infection rate 5%
        Increase in incidence of infection of 5%
        clinically significant
        Power 80%, Alpha 0.05 – equivalence test of
        357 patients in each group

    Results – Participants                                                                                      Baseline data
                                             Wound Management

                          Patients presenting for excisions during study period
                                                 n=1247                                                                                                     W e t (In te rv e n tio n )   D ry (C o n tro l)    p -v a lu e
                                                                                                                                                                    n= 450                     n= 420
                                                                                                                 M e a n (S D )* a g e [ye a rs]                5 5 .9 (∀ 1 6 .6 )         5 6 .5 (∀ 1 6 .2 )     0 .5 8
                                    Randomization                                 Excluded n=377
                                                                                                                 M a le p a t ie n t s (% )                     2 4 9 (5 5 .3 % )          2 0 8 (4 9 .5 % )      0 .0 8
                                                                         Not meeting inclusion criteria n=294
                                                                                                                 M e a n D ays (S D ) t o rem o v a l o f         8 .6 (∀ 2 .2 )            8 .6 (∀ 2 .2 )          1
                                                                             Refused to participate n=67
                                                                                Other reasons n=16               su t u re s
                                                                                                                 P re s en ce o f d ia b e t e s                    9 (2 % )                 1 4 (3 .3 % )         0 .2
                                                                                                                 H ist o ry o f o t h e r m e d ic a l             8 (1 .8 % )               1 0 (2 .3 % )         0 .5
             Wet n=450                                         Dry n=420                                         c o n d it io n * *
Received allocated intervention n=450             Received allocated intervention n=420                          T re a t e d w it h 1 % lig n o c a in e       4 3 5 (9 6 .7 % )          4 1 1 (9 7 .9 % )       0 .3
  Did not receive intervention n=0                  Did not receive intervention n=0                             a d re n a lin e
                                                                                                                 E x c isio n o f sk in c a n c er                2 9 4 (6 5 % )            2 8 9 (6 9 % )         0 .3
                                                                                                                 E x c isio n a t lo w e r lim b                  1 1 2 (2 5 % )            1 0 6 (2 5 % )           1
        Lost to follow up n=8                             Lost to follow up n=5
    Discontinued intervention n=0                     Discontinued intervention n=0

          Analysed n=442                                       Analysed n=415

Infection                                          Risk factors for infection
 Wet (intervention) 8.4%
 Dry (control) 8.9%                                 Multivariate analysis – independent
 Overall 8.6%                                       predictors of infection

 Incidences of infection in intervention group &    Lower legs and feet (p=0.009)
 control group significantly equivalent             Thighs (p=0.005)
                                                    BCC (p=0.006)
                                                    SCC (p=0.002)
                                                    Diabetes (p<0.001)
 95% confidence intervals 6.8,10.5

What did we excise?                                Limitations
                                                   Large number of variables

                                  melanoma         Inadequate data collection
                                  Naevus           Diagnosis of infection subjective
                                  Dysplastic N
                                  Seb wart         Compliance difficult to measure
                                  Solar K
                                  Other            Generalisability to temperate climate?

Conclusion                                         Publication

 Patients can uncover and wet sutures in first      Where???
 48hrs after minor skin excisions without
 increasing incidence of infection                  BMJ


                          PHCRED grant obtained as group

                          I was employed as principal researcher

                          GPs preferred practice nurses to be paid for their

                          Delegation of tasks

                          Design and methods developed as group

What went well           What went well

                          Trial ‘owned’ by GPs
                          Because trial initiated by themselves, GPs
                          enthusiastic, didn’t have to ‘sell’ it
                          Made welcome in practices, able to work with
                          practice nurses
                          Recruitment easy
                          Quality of data collection generally very good
                          PHCRED grant available quickly

What went not so well?   What went not so well

                          Not my choice of project


                          Difficult to delegate work

                          Difficult to sell rigor to GPs

                          Geographically compromised – more input at

Overall                                       The Future?
                                              ? New research project
 Successful project
                                              Infrastructure to study intervention to
 GPs and practice nurses pleasure to work     decrease infection rate

 Practice nurses excellent researchers

 GPs have to ‘own’ project to be successful

Thank you!
 Supervisors – Petra Buettner, Bev Raasch
 PHCRED JCU Townsville
 GPs in Mackay


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