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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253069

Enrollment

Registered

2014-10-01

Start date

2014-09-30

Completion date

2015-09-30

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infections

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.

Interventions

DEVICEApplying Prontosan antiseptic solution to tie-over dressings

Applying a PHMB-based antiseptic to tie-over dressings

DEVICEApplying Placebo to tie-over dressings

Placebo control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026