Dermotaxis v/s Loop Suture Technique for Closure of Fasciotomy Wounds : a Study of 50 Cases

November 3, 2016 updated by: Naveen Mittal, Government Medical College, Patiala
The fasciotomy incisions lead to large, unsightly, chronic wounds after surgical intervention. The classic management was split thickness skin grafting but it leads to insensate skin with 23% of people upset by the appearance of the wound and 12% forced to changed occupation. Since no skin loss has occurred with the fasciotomy and utilizing the dermal properties of creep, stress relaxation and load cycling closure can be achieved in a better way. Our hypothesis is that using dermatotraction approximation could be done using inexpensive equipment readily available in any standard operating room.

Study Overview

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/10/012461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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