PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

Surgical Site Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253069
• Other study ID #: Regionskane
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: December 8, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Site Infections
• Surgical Wound Infection

Intervention

Device:
• Applying Prontosan antiseptic solution to tie-over dressings
Applying a PHMB-based antiseptic to tie-over dressings
• Applying Placebo to tie-over dressings
Placebo control

Locations

Country	Name	City	State
Sweden	Department of dermatology, Skåne university hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Saleh K, Sonesson A, Persson B, Riesbeck K, Schmidtchen A. A descriptive study of bacterial load of full-thickness surgical wounds in dermatologic surgery. Dermatol Surg. 2011 Jul;37(7):1014-22. doi: 10.1111/j.1524-4725.2011.02040.x. Epub 2011 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	7 days	No