- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02956733
Dermotaxis v/s Loop Suture Technique for Closure of Fasciotomy Wounds : a Study of 50 Cases
Study Overview
Status
Intervention / Treatment
Detailed Description
25 cases each of fasciotomy will be closed either by dermotaxis or loop suture technique with the inclusion criteria being closed fractures, no concomitant skin loss, fracture related compartment syndrome and fasciotomy within 36 hrs. The fasciotomy incision will be either closed in a single stage by loop suture technique or gradually by dermotaxis once the edema settled between 3-5 days. The results will be graded as excellent if approximation could be achieved, good if sutures have to be applied for protective care and poor if they have to be grafted. In dermotaxis (Singhs skin traction) method two parallel kirschner wires (1.5mm) will be passed through the dermis on either side of the wound margins and interconnected by compression device consisting of threaded rod having two blocks and compression knob. Gradual compression will be applied daily at the rate of 1 turn/12hours on both sides of the wound.
The loop suture technique involves using corrugated drains and Ethilon no.1. It is an extension of the purse string suture technique where a surgical suture is passed as a running stitch in and out along the edge of a wound in such a way that when the ends of the suture are drawn tight the wound is closed. Two corrugated drains (1 & 2) will be anchored to the skin adjacent to the fasciotomy incision using Ethilon no.1. Then the sutures will be passed from one edge of the wound through the skin and corrugated drain to the other in an alternating fashion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The inclusion criteria being closed fractures, no concomitant skin loss, fracture related compartment syndrome and fasciotomy within 36 hours.
Exclusion Criteria:
- The exclusion criteria was open fractures, skin loss, non-fracture related compartment syndrome and presentation after 36 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: dermotaxis
In dermotaxis (Singhs skin traction) method two parallel kirschner wires (1.5mm) will be passed through the dermis on either side of the wound margins and interconnected by compression device consisting of threaded rod having two blocks and compression knob.
Gradual compression will be applied daily at the rate of 1 turn/12hours on both sides of the wound.
|
In dermotaxis (Singhs skin traction) method two parallel kirschner wires (1.5mm) will be passed through the dermis on either side of the wound margins and interconnected by compression device consisting of threaded rod having two blocks and compression knob.
Gradual compression will be applied daily at the rate of 1 turn/12hours on both sides of the wound.
|
Active Comparator: loop suture technique
The loop suture technique involves using corrugated drains and Ethilon no.1.
It is an extension of the purse string suture technique where a surgical suture is passed as a running stitch in and out along the edge of a wound in such a way that when the ends of the suture are drawn tight the wound is closed.
Two corrugated drains (1 & 2) will be anchored to the skin adjacent to the fasciotomy incision using Ethilon no.1.
Then the sutures will be passed from one edge of the wound through the skin and corrugated drain to the other in an alternating fashion.
|
The loop suture technique involves using corrugated drains and Ethilon no.1.
It is an extension of the purse string suture technique where a surgical suture is passed as a running stitch in and out along the edge of a wound in such a way that when the ends of the suture are drawn tight the wound is closed.
Two corrugated drains (1 & 2) will be anchored to the skin adjacent to the fasciotomy incision using Ethilon no.1.
Then the sutures will be passed from one edge of the wound through the skin and corrugated drain to the other in an alternating fashion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
wound closure
Time Frame: 3 weeks
|
The results will be graded as excellent if approximation could be achieved, good if sutures have to be applied for protective care and poor if they have to be grafted.
|
3 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/10/012461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.