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PHMB-based Antiseptic Use in Full-thickness Surgical Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02253069
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : December 9, 2015
Information provided by (Responsible Party):
Karim Saleh, 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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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. [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02253069

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Department of dermatology, Skåne university hospital
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
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Principal Investigator: Karim Saleh, MD Department of Dermatology, Skåne University Hospital, Lund
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Responsible Party: Karim Saleh, Dr., Region Skane Identifier: NCT02253069    
Other Study ID Numbers: Regionskane
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Surgical Wound Infection
Surgical Wound
Wound Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anti-Infective Agents, Local
Anti-Infective Agents