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Wound Closure After Total Knee Replacement

I

Indus Hospital and Health Network

Status

Terminated

Conditions

Wound of Knee

Treatments

Other: Staples versus sutures

Study type

Interventional

Funder types

Other

Identifiers

NCT03788239
IRD_IRB_2017_06_006

Details and patient eligibility

About

To compare the wound healing after total knee replacement wound closure with staples versus subcuticular prolene suture.

Full description

.Informed consent will be taken from all the patients who meet the inclusion and exclusion criteria and then will be randomized into one of the two study arms (Arm 1: will undergo wound closure with staples and Arm 2 wound closure with subcuticular prolene suture).

before the start of surgery. The primary investigator will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol i.e. they will be sequentially numbered, opaque sealed envelopes. Before opening the envelope, the primary investigator will write the patient's medical record number, date and will sign the envelope. The envelope will contain carbon paper which will transfer the data allocation paper inside.

Enrollment

211 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients undergoing primary total knee replacements for osteoarthritis or post-traumatic arthritis (diagnosed on X-rays and history)
  • Bilateral knee surgeries
  • Patients giving informed consent

Exclusion criteria

  • Patients having previous skin, neuromuscular or connective tissue disorder (confirmed by history)
  • Patients taking steroids (confirmed by history)
  • Body mass index > 30 (increases chances of wound dehiscence)
  • Lack of consent
  • Pregnant females (confirmed by history)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

211 participants in 2 patient groups

Arm 1
Experimental group
Description:
Right knee wound closure by staples and Left Knee wound closure by sutures
Treatment:
Other: Staples versus sutures
Arm 2
Experimental group
Description:
Right knee wound closure by sutures and Left Knee wound closure by staples
Treatment:
Other: Staples versus sutures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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