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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Puerto Rico

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Simple Interrupted Suture

    Procedure/Surgery

    In the control group, simple interrupted sutures will be used for wound closure after surgical repair of ankle fractures.

  • Subcuticular Suture

    Procedure/Surgery

    In the experimental group, subcuticular sutures will be used for wound closure after surgical repair of ankle fractures.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Subcuticular Suture GroupExperimental treatment 1 intervention
Group B: Simple Interrupted Suture GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 and 8 weeks post-op.

Secondary outcomes

1

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.

Time frame
2 and 8 weeks post-op.
2

Self-reported foot and ankle score (SEFAS)

Consists of 12 items related to pain, limping, swelling, and use of orthotics and walking.

Time frame
2 and 8 weeks post-op.

Other outcomes

Locations

This trial has no 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: