Wound Closure After Total Knee Replacement: Comparison Between Staples and Sutures.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wound of Knee
- Sponsor
- Indus Hospital and Health Network
- Enrollment
- 211
- Locations
- 1
- Primary Endpoint
- Wound healing
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
To compare the wound healing after total knee replacement wound closure with staples versus subcuticular prolene suture.
Detailed 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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Wound healing
Time Frame: Surgery till 1 year post-op
Wound healing will be assessed using Hollander Score
Complications
Time Frame: Surgery till 1 year post-op