Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial

University of Puerto Rico (UPR)

Status: Not yet enrolling

Conditions: Ankle Fractures

Treatments: Procedure: Simple Interrupted Suture; Procedure: Subcuticular Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT06496698

117966

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Subcuticular Suture Group

Experimental group

Description:

Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group.

Treatment:

Procedure: Subcuticular Suture

Simple Interrupted Suture Group

Active Comparator group

Description:

Simple interrupted Monocryl 3-0 sutures will be placed on patients in the control group.

Treatment:

Procedure: Simple Interrupted Suture