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In this prospective randomized controlled single-center trial, based on a non-inferiority design, the outcome of the treatment of patients are analyzed, whereas in half of the cases the wounds are left open and the other ones are primary wound closed after local debridement after Fixator-Extern is removed. Although this topic embodies a daily business, there is no standard to be found in literature regarding the treatment of pin sites with closure by either primary or secondary intent.
In the orthopedic department of the Kantonsspital Lucerne (LUKS) after removal of the external fixator, the pin sites at the tibia and the back of the foot are routinely treated with primary wound closure. An international survey carried out by the LUKS shows that in comparison to our standard treatment the majority of surgeons left the pin sites open during the healing process. In order to find a standardized method to treat pin sites we conduct a randomized controlled trial, in which half of the pin site wounds are left open and the other half are treated by primary wound closure after local debridement (Treatment of the first pin-side will be randomized, then alternated treatment of the consecutive pin-sides). All patients of the study participants are treated within a fixed pre- and postoperative protocol, which includes antibiotic prophylaxis with a single shot of Cefazolin 2g intravenously 30 minutes prior to surgery. The postoperative pin care includes daily inspection of the pin sites, cleaning the secondary healing wound with Ringerfundin © and disinfection with Betadine ©. Primary wound closures are dressed with dry gaze bandage. The following out-patient treatment is provided either by a Spitex support, the family doctor or by the patient himself, depending on the patients compliance. Regular follow-up consultations at 2, 6, 12, 24 and 52 weeks after surgery ensure an adequate surveillance of the healing process, whereas the examining doctor at the second and last consultation was kept in dark what therapy was chosen for pin sites of the patient. To objectify the clinical progress the pin sites are photo documented at the consultations at week 2 and 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary wound healing | Active Comparator | Primary woundclosure in Allgöwer suture technique |
|
| Secondary wound healing | No Intervention | no closure, open wound healing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe | Procedure | We compare the outcome of primary wound closure (Allgower) and secondary open wound healing by comparing infection-rates, use of antibiotics, reoperation-rates, satisfaction of the patients and optical results using the Vancouver scar scale |
| Measure | Description | Time Frame |
|---|---|---|
| Post surgical pin side wound infections according to center of disease control (CDC) | up to 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical wound revision of the pin sides, carried out antibiotic therapy in a wound infection | up to 52 weeks after surgery | |
| Time to wound healing of the pin sides | Definition wound healing: complete epithelialization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzerner Kantonsspital | Lucerne | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36622896 | Derived | Tillmann F, Hoepelman RJ, Cagienard F, Link BC, Babst R, van de Wall BJM, Beeres FJP. Primary Closure or Secondary Wound Healing of Pin Sites After External Fixator Removal: A Single-Center Blinded Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):207-213. doi: 10.2106/JBJS.22.00234. Epub 2023 Jan 9. | |
| 32075685 |
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Blinded in the 6- and 52-weeks examination. So the doctor doesn't know which pin-side is treated by primary woundclosure (Allgower) or by secondary wound healing
|
| up to 6 weeks after surgery |
| Vancouver scar scale | ExercisingPigmentation 0-2, Vascularity 0-3, Pliability 0-5, Height 0-3, so that the score has got a total score reaching from 0 up to 13 | up to 52 weeks after surgery |
| subjective perception of the wounds | questionnaire on subjective preference of the patient | up to 52 weeks after surgery |
| Roth F, Cagienard F, Link BC, Hodel S, Lehnick D, Babst R, Beeres FJP. Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial. Trials. 2020 Feb 19;21(1):205. doi: 10.1186/s13063-020-4087-8. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
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