PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

Region Skane

Status: Completed

Conditions: Surgical Site Infections

Treatments: Device: Applying Placebo to tie-over dressings; Device: Applying Prontosan antiseptic solution to tie-over dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT02253069

Regionskane

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

PHMB-based antiseptic

Experimental group

Description:

Applying Prontosan antiseptic solution to tie-over dressings

Treatment:

Device: Applying Prontosan antiseptic solution to tie-over dressings

Control

Placebo Comparator group

Description:

Applying water to tie-over dressings

Treatment:

Device: Applying Placebo to tie-over dressings