Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06496698
Enrollment
80
Registered
2024-07-11
Start date
2024-07-15
Completion date
2026-07-15
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures

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.

Interventions

PROCEDURESimple Interrupted Suture

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

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

Sponsors

University of Puerto Rico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Complication rates2 and 8 weeks post-op.Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery.

Secondary

MeasureTime frameDescription
Patient and Observer Scar Assessment Scale (POSAS)2 and 8 weeks post-op.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)2 and 8 weeks post-op.Consists of 12 items related to pain, limping, swelling, and use of orthotics and walking.

Contacts

Primary ContactJosé Acosta, MD
jose.acosta14@upr.edu787-758-2525
Backup ContactCarlos Guevara, MD
Carlos.guevara2@upr.edu787-758-2525‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026