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NCT Number: NCT02253069

PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

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.

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Key information

Conditions

Surgical Site Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of dermatology, Skåne university hospital

Lund, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Applying Prontosan antiseptic solution to tie-over dressings

Device

Applying a PHMB-based antiseptic to tie-over dressings

Applying Placebo to tie-over dressings

Device

Placebo control

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.

    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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Vinnova

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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