NCT02253069

PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Site Infections

Interventions

Type	Name	Description
DEVICE	Applying Prontosan antiseptic solution to tie-over dressings	Applying a PHMB-based antiseptic to tie-over dressings
DEVICE	Applying Placebo to tie-over dressings	Placebo control

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-10-01
• Last updated: 2015-12-09

Locations

1 site across 1 country: Sweden