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PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

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ClinicalTrials.gov Identifier: NCT02253069
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Vinnova
Information provided by (Responsible Party):
Karim Saleh, Region Skane

Tracking Information
First Submitted Date  ICMJE September 24, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
Measuring colony forming units in swabs collected from wounds pre-,intra- and postoperatively (7 days after surgery1). Change in bacterial load will be attributed to the effect of applying an antiseptic solution to wound dressings. [ Time Frame: 7 days ]
Wounds will be swabbed at end of surgery and then 7 days after surgery. Number and type of bacteria present will be analysed. Our hypothesis is that applying the antiseptic solution to the tie-over dressings will show a suppressed growth of bacteria when measured 7 days after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PHMB-based Antiseptic Use in Full-thickness Surgical Wounds
Official Title  ICMJE A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery
Brief Summary To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in full-thickness surgical wounds in dermatologic surgery in order to minimise the development of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and postoperatively will be examined in order to understand the pathogenesis of surgical site infections better.
Detailed Description 40 patients with suspected skin cancer in the face planned for full-thickness surgery will be randomised into two groups: One will receive a traditional tie-over dressing saturated with NaCl and the other group will receive a tie-over dressing saturated with a PHMB-based antiseptic. A quantitative and qualitative bacterial analysis of wounds by using a modified Levine's swabbing technique will be carried out pre-,intra-,and postoperatively. The effect of nasal colonisation with S.aureus on the development of surgical site infections will be investigated. All wounds will be followed a week after surgery to assess development of infections.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Surgical Site Infections
Intervention  ICMJE
  • Device: Applying Prontosan antiseptic solution to tie-over dressings
    Applying a PHMB-based antiseptic to tie-over dressings
  • Device: Applying Placebo to tie-over dressings
    Placebo control
Study Arms  ICMJE
  • Experimental: PHMB-based antiseptic
    Applying Prontosan antiseptic solution to tie-over dressings
    Intervention: Device: Applying Prontosan antiseptic solution to tie-over dressings
  • Placebo Comparator: Control
    Applying water to tie-over dressings
    Intervention: Device: Applying Placebo to tie-over dressings
Publications * Saleh K, Sonesson A, Persson B, Riesbeck K, Schmidtchen A. A descriptive study of bacterial load of full-thickness surgical wounds in dermatologic surgery. Dermatol Surg. 2011 Jul;37(7):1014-22. doi: 10.1111/j.1524-4725.2011.02040.x. Epub 2011 May 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients planned for full-thickness skin grafting in the face

Exclusion Criteria:

  • Patients with no diabetes
  • Patients with no current/previous/recent antibiotic therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02253069
Other Study ID Numbers  ICMJE Regionskane
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Karim Saleh, Region Skane
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Region Skane
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Vinnova
Investigators  ICMJE
Principal Investigator: Karim Saleh, MD Department of Dermatology, Skåne University Hospital, Lund
PRS Account Region Skane
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP