The Effect of a vapour-permeable film and absorbent dressing on wound after ankle fracture surgery in diabetic patients: double blinded randomized controlled stud

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009246

Enrollment

Registered

2024-03-15

Start date

2022-06-29

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Patients who meet the criteria are randomized to treat with Mepilex® Border post-op dressing or simple gauze dressing at a 1:1 ratio by block randomization using pre-prepared alloc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with ankle fracture (lateral malleolar, medial malleolar, bimalleolar, trimalleolar) (2) Age same or over 19 (3) Type 1 or Type 2 diabetes patients with HbA1c < 10% (4) Patients who has voluntarilly agreed to a consent form

Exclusion criteria

Exclusion criteria: (1) Patients with open fracture (2) Patients with Pilon fracture (3) Patients with multiple fracutre or injury (4) Patients with dermatological problems near the incision site (5) Pregnant patients (5) Patients with complications that can affect wound healing (e.g., autoimmune diseases, immunodeficiency diseases, etc.) (7) Patients who has not voluntarilly agreed to a consent form

Design outcomes

Primary

Measure	Time frame
Clinical assessment of wound (wound invasion, skin epidermis dissolution, eschar formation, total thickness necrosis and dehiscence in the target surgical wound	—

Secondary

Measure	Time frame
Patients' satisfication (score 0 ~ 10)	—

Countries

Korea, Republic of

Contacts

Public ContactSung Hyun Lee

Wonkwang University Hospital

kensin06@hanmail.net+82-2-859-1360

Outcome results