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

NCT ID: NCT06496698

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2026-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subcuticular Suture Group

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

Group Type EXPERIMENTAL

Subcuticular Suture

Intervention Type PROCEDURE

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

Simple Interrupted Suture Group

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

Group Type ACTIVE_COMPARATOR

Simple Interrupted Suture

Intervention Type PROCEDURE

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

Interventions

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Simple Interrupted Suture

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

Intervention Type PROCEDURE

Subcuticular Suture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Puerto Rico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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José Acosta, MD

Role: CONTACT

787-758-2525 ext. 1907

Carlos Guevara, MD

Role: CONTACT

787-758-2525‬ ext. 1908

Other Identifiers

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117966

Identifier Type: -

Identifier Source: org_study_id

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