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

NCT06496698 | Not Yet Recruiting

• 1 other identifier: 117966
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ankle Fractures

Outcome Measures

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.

  2 and 8 weeks post-op.

Secondary Outcomes (2)

• Patient and Observer Scar Assessment Scale (POSAS)

  2 and 8 weeks post-op.

• Self-reported foot and ankle score (SEFAS)

  2 and 8 weeks post-op.

Study Arms (2)

Subcuticular Suture Group

EXPERIMENTAL

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

Procedure: Subcuticular Suture

Simple Interrupted Suture Group

ACTIVE COMPARATOR

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

Procedure: Simple Interrupted Suture

Interventions

Simple Interrupted Suture PROCEDURE

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

Simple Interrupted Suture Group

Subcuticular Suture PROCEDURE

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

Subcuticular Suture Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Puerto Rico: lead

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Central Study Contacts

José Acosta, MD

CONTACT

787-758-2525; jose.acosta14@upr.edu

Carlos Guevara, MD

CONTACT

787-758-2525‬; Carlos.guevara2@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-06