Fracture External Fixation Pin Site Wound Wound Healing Lower Extremity Injury External Fixation Fracture Wound Healing Adhesive strip Steri-strip Surgical Wound Infection Lower Extremity Randomized Controlled Trial
Conditions
Interventions
Pin-site wounds allocated to Arm 1 will undergo primary closure using sterile adhesive skin closure strips immediately after external fixator removal,Pin-site wounds allocated to Arm 2 will be left op
Adhesive strip Primary closure,Secondary intention healing
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older at the time of enrollment. 2.Sustained a lower extremity fracture and underwent temporary stabilization with an external fixator at the femur and/or tibia. 3.Able to attend follow-up visits and assessments for at least 12 weeks after definitive fixation surgery. 4.Provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Immunocompromised state (e.g., HIV infection, hepatitis, leukemia, corticosteroid use, autoimmune disease, or use of immunosuppressive medications). 2.Unable to return for follow-up at King Chulalongkorn Memorial Hospital. 3.History of substance abuse. 4.Required wound closure by primary closure as part of necessary surgical treatment (e.g., internal fixation performed directly beneath the pin-site wound). 5.Unable to communicate in Thai. 6.Unable to complete questionnaires. 7.Unable to provide informed consent. 8.Patients who received an external fixator for ligamentous injury or vascular injury without an associated fracture, or for deformity correction. 9.Presence of pin-site infection prior to removal of the external fixator. 10.Duration of external fixator application longer than 30 days. 11.External fixator used as definitive treatment. 12.Patients treated with an Ilizarov frame.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete wound healing up to 12 weeks after definitive surgery Days from external fixator removal to complete epithelialization without discharge or need for dressing | — |
Secondary
| Measure | Time frame |
|---|---|
| Pin-site infection within 12 weeks after definitive surgery Incidence of clinical pin-site infection assessed according to CDC surgical site infection criteria,Pain score Postoperative 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks Visual Analog Scale (VAS), 0-10,Scar quality Postoperative 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks Vancouver Scar Scale (VSS) ,Complete wound healing rate at 2 weeks 2 weeks after definitive surgery Proportion of pin-site wounds completely healed at postoperative 2 weeks,Surgical site infection within 12 weeks after definitive surgery Incidence of surgical site infection at definitive fixation site assessed according to CDC surgical site infection criteria,Other complications within 12 weeks after definitive surgery Incidence of adverse events or complications related to treatment | — |
Countries
Thailand
Contacts
Public ContactThitivuth Wisan
Department of Orthopaedics, Faculty of Medicine, Chulalongkorn University, Thailand
Outcome results
None listed