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

NCT ID: NCT03842956

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Primary wound healing

Primary woundclosure in Allgöwer suture technique

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

Secondary wound healing

no closure, open wound healing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Reto Babst

Head of Traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Luzerner Kantonsspital

Lucerne, , Switzerland

Countries

Switzerland

References

Tillmann F, Hoepelman RJ, Cagienard F, Link BC, Babst R, van de Wall BJM, Beeres FJP. Primary Closure or Secondary Wound Healing of Pin Sites After External Fixator Removal: A Single-Center Blinded Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):207-213. doi: 10.2106/JBJS.22.00234. Epub 2023 Jan 9.

Reference Type: DERIVED

PMID: 36622896 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32075685 (View on PubMed)

Other Identifiers

2018-01316

Identifier Type: -

Identifier Source: org_study_id