Surgical Site InfectionsNCT02253069
PHMB-based Antiseptic Use in Full-thickness Surgical Wounds
A study testing Applying Prontosan antiseptic solution to tie-over dressings in people with Surgical Site Infections, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- Applying Prontosan antiseptic solution to tie-over dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients planned for full-thickness skin grafting in the face
Who cannot join
- Patients with no diabetes
- Patients with no current/previous/recent antibiotic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery
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.
Read the 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.
- Conditions
- Surgical Site Infections
- Being tested
- Applying Prontosan antiseptic solution to tie-over dressings, Applying Placebo to tie-over dressings
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applying Prontosan antiseptic solution to tie-over dressingsDevice
Applying a PHMB-based antiseptic to tie-over dressings
Applying Placebo to tie-over dressingsDevice
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| PHMB-based antiseptic | Experimental | Applying Prontosan antiseptic solution to tie-over dressings Receives: Device: Applying Prontosan antiseptic solution to tie-over dressings |
| Control | Placebo comparator | Applying water to tie-over dressings Receives: Device: Applying Placebo to tie-over dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova
- Responsible party
- Principal investigator, Karim Saleh, Region Skane
- Investigators
- Karim Saleh, MD, Principal investigator, Department of Dermatology, Skåne University Hospital, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253069
- Sponsor's protocol ID
- Regionskane
- Status last verified
- Dec 2015
- First submitted
- 24 Sep 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21615603
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery
- ClinicalTrials.gov ID
- NCT02253069
- Acronym / sponsor ID
- Regionskane
- Conditions
- Surgical Site Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Vinnova
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHMB-based antiseptic | Experimental | Device: Applying Prontosan antiseptic solution to tie-over dressingsApplying Prontosan antiseptic solution to tie-over dressings |
| Control | Placebo comparator | Device: Applying Placebo to tie-over dressingsApplying water to tie-over dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients planned for full-thickness skin grafting in the face
Key exclusion criteria (2 listed)
- Patients with no diabetes
- Patients with no current/previous/recent antibiotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applying Prontosan antiseptic solution to tie-over dressingsApplying a PHMB-based antiseptic to tie-over dressings | Device | PHMB-based antiseptic |
| Applying Placebo to tie-over dressingsPlacebo control | Device | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 21615603Saleh 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.
Related trials for Surgical Site Infections
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruiting
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
Active, not recruiting
Effectiveness of Digital Game-Based Learning in Teaching Surgical Site Infection Prevention to Nursing Students
Surgical Site Infection Prevention, Nursing Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Saleh, MD principal investigator
Department of Dermatology, Skåne University Hospital, Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applying Prontosan antiseptic solution to tie-over dressings in people with Surgical Site Infections, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015; AzTrials last refreshed its copy on 2 Nov 2026.