Wound Closure (Allgower) Versus Secondary Open Wound Healing After Removal of the External Fixator

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Wound Closure (Allgower) Versus Secondary Open Wound Healing of the Pin Sites After Removal of the External Fixator: Study Protocol for a Prospective, Randomized Controlled Mono-center Trial

Conditions
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Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External Fixator

Intervention / Treatment
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* Procedure: Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed 18th year of age Supply by external fixator Signed informed consent for study participation Exclusion Criteria: Patients with immunodeficiency (HIV / hepatitis infection, leukemia, steroid therapy, autoimmune therapy) Patients who can not perform a follow-up treatment for structural reasons (tourists, not home canton) or other reasons Lack of knowledge of German Lack of consent to study participation invalid patients
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary wound healing<br>Primary woundclosure in Allgöwer suture technique | Procedure: Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe<br>* 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<br>|
| No Intervention: Secondary wound healing<br>no closure, open wound healing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post surgical pin side wound infections according to center of disease control (CDC) |  | up to 12 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fixator extern, Fixateur externe, External fixator, Wound healing, Fix-Ex, Pin Side, Trauma, Infection