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Study protocol
Primary or secondary wound healing of the Pin Sites After Removal of the External Fixator: Study Protocol for a Prospective, Randomized Controlled Mono-center Trial
Franz Roth
Luzerner Kantonsspital
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9960-0548
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Temporary fixation with an external fixator is used for numerous indications in orthopedic trauma surgery. It is unclear whether primary wound healing or the secondary open wound healing after removal of the external fixator should be advocated for the pin site. This study compares primary wound closure with secondary wound healing for the pin sites. The primary aim is to compare the infections rates of the pin site. Secondary aim is to compare time to wound healing and esthetic outcome. The hypothesis was that primary wound closure does not lead to more infections than secondary wound healing. Methods: This is a prospective, randomized, controlled and blinded monocenter study based on a non-inferiority design. To obtain an equal patient population and groups, all pin entry sites of the patients are treated alternately at the time of removal of the external fixator with primary wound closure and secondary wound healing. Patients are randomized whether the proximal pin entry site is treated with wound closure or by secondary open wound healing, from which the further sequence develops. The pre- and postoperative protocol is standardized for all pin entry sites. A photo documentation of the pin entry sites takes place 2 and 52 weeks postoperatively during the routine clinically follow-up visits. Further controls take place after 6, 12 and 26 weeks after the removal. The primary outcome was to demonstrate the non-inferiority of primary wound closure compared to secondary wound healing in terms of postoperative wound infections according to center of disease control (CDC). The secondary outcomes are time to complete wound healing (days) and esthetical outcome (Subjective preference of patients and Vancouver scar scale). Discussion: This study aims in answering how to deal with the pin site after removal of the external fixator. To date, no routine and generally accepted protocol exists for the management of pin sites after removal of the external fixator. This prospective, randomized, blinded monocenter trial will answer if primary wound closure or secondary wound healing should be advocated after removal of the external fixator.
Keywords
Fixator extern, Fixateur externe, External fixator, Wound healing, Fix-Ex, Pin Site, Trauma, Infection, Pin tract infection.
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CURRENT STATUS: Published
Version 3
Posted 17 Jan, 2020
Published
On 19 Feb, 2020
No community comments so far
Editorial decision: Accept
On 18 Jan, 2020
Editor assigned
On 16 Jan, 2020
Submission checks complete
On 15 Jan, 2020
No comments provided
Editorial decision: Minor revision
On 11 Jan, 2020
Review #2 received
Received 10 Jan, 2020
Reviewer #1 agreed
On 07 Jan, 2020
Reviewer #2 agreed
On 07 Jan, 2020
Review #1 received
Received 07 Jan, 2020
Editor assigned
On 06 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Submission checks complete
On 05 Jan, 2020
No comments provided
Editorial decision: Major revision
On 06 Dec, 2019
Review #1 received
Received 03 Oct, 2019
Review #2 received
Received 03 Oct, 2019
Reviewer #2 agreed
On 26 Sep, 2019
Reviewers invited
Invitations sent on 25 Sep, 2019
Reviewer #1 agreed
On 25 Sep, 2019
Editor assigned
On 24 Sep, 2019
Submission checks complete
On 19 Aug, 2019
First submitted
On 17 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Primary or secondary wound healing of the Pin Sites After Removal of the External Fixator: Study Protocol for a Prospective, Randomized Controlled Mono-center Trial
Franz Roth
Luzerner Kantonsspital
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9960-0548
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 3
Posted 17 Jan, 2020
Published
On 19 Feb, 2020
No community comments so far
Editorial decision: Accept
On 18 Jan, 2020
Editor assigned
On 16 Jan, 2020
Submission checks complete
On 15 Jan, 2020
No comments provided
Editorial decision: Minor revision
On 11 Jan, 2020
Review #2 received
Received 10 Jan, 2020
Reviewer #1 agreed
On 07 Jan, 2020
Reviewer #2 agreed
On 07 Jan, 2020
Review #1 received
Received 07 Jan, 2020
Editor assigned
On 06 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Submission checks complete
On 05 Jan, 2020
No comments provided
Editorial decision: Major revision
On 06 Dec, 2019
Review #1 received
Received 03 Oct, 2019
Review #2 received
Received 03 Oct, 2019
Reviewer #2 agreed
On 26 Sep, 2019
Reviewers invited
Invitations sent on 25 Sep, 2019
Reviewer #1 agreed
On 25 Sep, 2019
Editor assigned
On 24 Sep, 2019
Submission checks complete
On 19 Aug, 2019
First submitted
On 17 Aug, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Temporary fixation with an external fixator is used for numerous indications in orthopedic trauma surgery. It is unclear whether primary wound healing or the secondary open wound healing after removal of the external fixator should be advocated for the pin site. This study compares primary wound closure with secondary wound healing for the pin sites. The primary aim is to compare the infections rates of the pin site. Secondary aim is to compare time to wound healing and esthetic outcome. The hypothesis was that primary wound closure does not lead to more infections than secondary wound healing. Methods: This is a prospective, randomized, controlled and blinded monocenter study based on a non-inferiority design. To obtain an equal patient population and groups, all pin entry sites of the patients are treated alternately at the time of removal of the external fixator with primary wound closure and secondary wound healing. Patients are randomized whether the proximal pin entry site is treated with wound closure or by secondary open wound healing, from which the further sequence develops. The pre- and postoperative protocol is standardized for all pin entry sites. A photo documentation of the pin entry sites takes place 2 and 52 weeks postoperatively during the routine clinically follow-up visits. Further controls take place after 6, 12 and 26 weeks after the removal. The primary outcome was to demonstrate the non-inferiority of primary wound closure compared to secondary wound healing in terms of postoperative wound infections according to center of disease control (CDC). The secondary outcomes are time to complete wound healing (days) and esthetical outcome (Subjective preference of patients and Vancouver scar scale). Discussion: This study aims in answering how to deal with the pin site after removal of the external fixator. To date, no routine and generally accepted protocol exists for the management of pin sites after removal of the external fixator. This prospective, randomized, blinded monocenter trial will answer if primary wound closure or secondary wound healing should be advocated after removal of the external fixator.
Figure 1
Figure 2
Figure 3