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| Name | Class |
|---|---|
| Vinnova | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHMB-based antiseptic | Experimental | Applying Prontosan antiseptic solution to tie-over dressings |
|
| Control | Placebo Comparator | Applying water to tie-over dressings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Applying Prontosan antiseptic solution to tie-over dressings | Device | Applying a PHMB-based antiseptic to tie-over dressings |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karim Saleh, MD | Department of Dermatology, Skåne University Hospital, Lund | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of dermatology, Skåne university hospital | Lund | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21615603 | Background | 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. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Applying Placebo to tie-over dressings | Device | Placebo control |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |