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PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

NCT ID: NCT02253069

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

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.

Conditions

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Surgical Site Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PHMB-based antiseptic

Applying Prontosan antiseptic solution to tie-over dressings

Group Type EXPERIMENTAL

Applying Prontosan antiseptic solution to tie-over dressings

Intervention Type DEVICE

Applying a PHMB-based antiseptic to tie-over dressings

Control

Applying water to tie-over dressings

Group Type PLACEBO_COMPARATOR

Applying Placebo to tie-over dressings

Intervention Type DEVICE

Placebo control

Interventions

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Applying Prontosan antiseptic solution to tie-over dressings

Applying a PHMB-based antiseptic to tie-over dressings

Intervention Type DEVICE

Applying Placebo to tie-over dressings

Placebo control

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vinnova

OTHER_GOV

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Karim Saleh

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karim Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Skåne University Hospital, Lund

Locations

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Department of dermatology, Skåne university hospital

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 21615603 (View on PubMed)

Other Identifiers

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Regionskane

Identifier Type: -

Identifier Source: org_study_id