PHMB-based Antiseptic Use in Full-thickness Surgical Wounds
A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedDecember 9, 2015
December 1, 2015
1 year
September 24, 2014
December 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
7 days
Study Arms (2)
PHMB-based antiseptic
EXPERIMENTALApplying Prontosan antiseptic solution to tie-over dressings
Control
PLACEBO COMPARATORApplying water to tie-over dressings
Interventions
Applying a PHMB-based antiseptic to tie-over dressings
Eligibility Criteria
You may qualify if:
- Patients planned for full-thickness skin grafting in the face
You may not qualify if:
- Patients with no diabetes
- Patients with no current/previous/recent antibiotic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Vinnovacollaborator
Study Sites (1)
Department of dermatology, Skåne university hospital
Lund, 22185, Sweden
Related Publications (1)
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.
PMID: 21615603BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karim Saleh, MD
Department of Dermatology, Skåne University Hospital, Lund
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
September 24, 2014
First Posted
October 1, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-12