PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

Not Applicable

Completed

• Conditions: Surgical Site Infections
• Interventions: Device: Applying Prontosan antiseptic solution to tie-over dressings; Device: Applying Placebo to tie-over dressings

• Registration Number: NCT02253069
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHMB-based antiseptic	Applying Prontosan antiseptic solution to tie-over dressings	Applying Prontosan antiseptic solution to tie-over dressings
Control	Applying Placebo to tie-over dressings	Applying water to tie-over dressings

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Department of dermatology, Skåne university hospital; 🇸🇪 Lund, Sweden