Clinical trial NCT03842956: Wound Closure (Allgower) Versus Secondary Open Wound Healing After Removal of the External Fixator
Official title: "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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External Fixator
Keywords: Fixator extern
Fixateur externe
External fixator
Wound healing
Fix-Ex
Pin Side
Trauma
Infection
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 241
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post surgical pin side wound infections according to center of disease control (CDC)
timeFrame: up to 12 weeks after surgery
Secondary outcomes:
measure: Surgical wound revision of the pin sides, carried out antibiotic therapy in a wound infection
timeFrame: up to 52 weeks after surgery
measure: Time to wound healing of the pin sides
timeFrame: up to 6 weeks after surgery
measure: Vancouver scar scale
timeFrame: up to 52 weeks after surgery
measure: subjective perception of the wounds
timeFrame: up to 52 weeks after surgery
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
References:
citation: 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.