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JOURNAL ONKOLOGIE – STUDIE
Pinsides

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

Rekrutierend

NCT-Nummer:
NCT03842956

Studienbeginn:
Januar 2019

Letztes Update:
23.02.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Wounds and Injuries, Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Luzerner Kantonsspital

Collaborator:
-

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Post surgical pin side wound infections according to center of disease control (CDC) (Time Frame - up to 12 weeks after surgery)



Secondary outcome:

1. Surgical wound revision of the pin sides, carried out antibiotic therapy in a wound infection (Time Frame - up to 52 weeks after surgery)

2. Time to wound healing of the pin sides (Time Frame - up to 6 weeks after surgery):
Definition wound healing: complete epithelialization

3. 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

4. subjective perception of the wounds (Time Frame - up to 52 weeks after surgery):
questionnaire on subjective preference of the patient

Studien-Arme

  • Active Comparator: Primary wound healing
    Primary woundclosure in Allgöwer suture technique
  • No Intervention: Secondary wound healing
    no closure, open wound healing

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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