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

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ClinicalTrials.gov Identifier: NCT02956733
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Naveen Mittal, Government Medical College, Patiala

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inexpensive Closure of Fasciotomy Incisions Without the Need for Skin Grafting Procedure: dermotaxis Procedure: loop suture technique Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dermotaxis v/s Loop Suture Technique for Closure of Fasciotomy Wounds : a Study of 50 Cases
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.
Procedure: 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.

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.
Procedure: 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Naveen Mittal, senior resident department of orthopaedics, Government Medical College, Patiala
ClinicalTrials.gov Identifier: NCT02956733     History of Changes
Other Study ID Numbers: 2016/10/012461
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Naveen Mittal, Government Medical College, Patiala:
inexpensive, fasciotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Surgical Wound
Wounds and Injuries