An interventional study of Simple Interrupted Suture and Subcuticular Suture in Ankle Fractures, sponsored by University of Puerto Rico. Status unknown. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by University of Puerto Rico · Not applicable, Interventional, and Treatment
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.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 80 is below the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →University of Puerto Rico is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
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Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group.
Procedure: Subcuticular Suture
Simple interrupted Monocryl 3-0 sutures will be placed on patients in the control group.
Procedure: Simple 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.
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.
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.
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.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Jul 2026, 24 months later.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 24 months is below that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Puerto Rico