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PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

Primary Purpose

Surgical Site Infections

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Applying Prontosan antiseptic solution to tie-over dressings
Applying Placebo to tie-over dressings
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of dermatology, Skåne university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PHMB-based antiseptic

Control

Arm Description

Applying Prontosan antiseptic solution to tie-over dressings

Applying water to tie-over dressings

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2014
Last Updated
December 8, 2015
Sponsor
Region Skane
Collaborators
Vinnova
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1. Study Identification

Unique Protocol Identification Number
NCT02253069
Brief Title
PHMB-based Antiseptic Use in Full-thickness Surgical Wounds
Official Title
A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Vinnova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PHMB-based antiseptic
Arm Type
Experimental
Arm Description
Applying Prontosan antiseptic solution to tie-over dressings
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Applying water to tie-over dressings
Intervention Type
Device
Intervention Name(s)
Applying Prontosan antiseptic solution to tie-over dressings
Intervention Description
Applying a PHMB-based antiseptic to tie-over dressings
Intervention Type
Device
Intervention Name(s)
Applying Placebo to tie-over dressings
Intervention Description
Placebo control
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Saleh, MD
Organizational Affiliation
Department of Dermatology, Skåne University Hospital, Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of dermatology, Skåne university hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21615603
Citation
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.
Results Reference
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PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

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