About this trial
Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.
Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.
Disqualifiers
Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.
Trial design
Parallel
Treatments tested in this trial
Simple Interrupted Suture
Procedure/SurgeryIn the control group, simple interrupted sutures will be used for wound closure after surgical repair of ankle fractures.
Subcuticular Suture
Procedure/SurgeryIn the experimental group, subcuticular sutures will be used for wound closure after surgical repair of ankle fractures.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Complication rates
Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery.
Secondary outcomes
Patient and Observer Scar Assessment Scale (POSAS)
The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive tool used to evaluate the quality of scars from both the patient's and observer's perspectives. It consists of two parts: the Patient Scale and the Observer Scale.
Self-reported foot and ankle score (SEFAS)
Consists of 12 items related to pain, limping, swelling, and use of orthotics and walking.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: