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

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

— Pinsides  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842956
• Other study ID #: 2018-01316
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2022
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External Fixator
• Neoplasm Metastasis
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post surgical pin side wound infections according to center of disease control (CDC)		up to 12 weeks after surgery
Secondary	Surgical wound revision of the pin sides, carried out antibiotic therapy in a wound infection		up to 52 weeks after surgery
Secondary	Time to wound healing of the pin sides	Definition wound healing: complete epithelialization	up to 6 weeks after surgery
Secondary	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
Secondary	subjective perception of the wounds	questionnaire on subjective preference of the patient	up to 52 weeks after surgery