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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Switzerland
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Primary wound healing
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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luzerner Kantonsspital

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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