PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT02253069

Collaborator

Vinnova (Other)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infections	Device: Applying Prontosan antiseptic solution to tie-over dressings Device: Applying Placebo to tie-over dressings	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PHMB-based antiseptic Applying Prontosan antiseptic solution to tie-over dressings	Device: Applying Prontosan antiseptic solution to tie-over dressings Applying a PHMB-based antiseptic to tie-over dressings
Placebo Comparator: Control Applying water to tie-over dressings	Device: Applying Placebo to tie-over dressings Placebo control

Arm

Intervention/Treatment

Experimental: PHMB-based antiseptic

Applying Prontosan antiseptic solution to tie-over dressings

Device: Applying Prontosan antiseptic solution to tie-over dressings

Applying a PHMB-based antiseptic to tie-over dressings

Placebo Comparator: Control

Applying water to tie-over dressings

Device: Applying Placebo to tie-over dressings

Placebo control

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of dermatology, Skåne university hospital	Lund		Sweden	22185

Sponsors and Collaborators

Region Skane
Vinnova

Investigators

Principal Investigator: Karim Saleh, MD, Department of Dermatology, Skåne University Hospital, Lund

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Karim Saleh, Dr., Region Skane

ClinicalTrials.gov Identifier:

NCT02253069

Other Study ID Numbers:

Regionskane

First Posted:

Oct 1, 2014

Last Update Posted:

Dec 9, 2015

Last Verified:

Dec 1, 2015

Additional relevant MeSH terms:

Surgical Wound Infection

Surgical Wound

Anti-Infective Agents, Local

Study Results

No Results Posted as of Dec 9, 2015