PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery

Conditions
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Surgical Site Infections

Intervention / Treatment
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* Device: Applying Prontosan antiseptic solution to tie-over dressings
* Device: Applying Placebo to tie-over dressings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PHMB-based antiseptic<br>Applying Prontosan antiseptic solution to tie-over dressings | Device: Applying Prontosan antiseptic solution to tie-over dressings<br>* Applying a PHMB-based antiseptic to tie-over dressings<br>|
| Placebo Comparator: Control<br>Applying water to tie-over dressings | Device: Applying Placebo to tie-over dressings<br>* Placebo control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |