Wound Closure (Allgower) Versus Secondary Open Wound Healing After Removal of the External Fixator (Pinsides)
August 6, 2022 updated by: Reto Babst, Luzerner Kantonsspital
"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"
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lucerne, Switzerland
- Luzerner Kantonsspital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Primary wound healing
Primary woundclosure in Allgöwer suture technique
|
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
|
|
NO_INTERVENTION: Secondary wound healing
no closure, open wound healing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post surgical pin side wound infections according to center of disease control (CDC)
Time Frame: up to 12 weeks after surgery
|
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
Time Frame: up to 52 weeks after surgery
|
up to 52 weeks after surgery
|
|
|
Time to wound healing of the pin sides
Time Frame: up to 6 weeks after surgery
|
Definition wound healing: complete epithelialization
|
up to 6 weeks after surgery
|
|
Vancouver scar scale
Time Frame: up to 52 weeks after surgery
|
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
Time Frame: up to 52 weeks after surgery
|
questionnaire on subjective preference of the patient
|
up to 52 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2019
Primary Completion (ACTUAL)
February 28, 2021
Study Completion (ACTUAL)
February 28, 2021
Study Registration Dates
First Submitted
February 8, 2019
First Submitted That Met QC Criteria
February 14, 2019
First Posted (ACTUAL)
February 15, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 9, 2022
Last Update Submitted That Met QC Criteria
August 6, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-01316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.