Wound of Knee
Conditions
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.
Interventions
OTHERStaples versus sutures
Prolene suture: non-absorbable, sterile surgical suture composed of an isotactic crystalline steroisomer of polypropylene, a synthetic linear polyolefin. After completion of the procedure, deep tissues will closed with subcuticular prolene suture. Compared to the absorbable sutures, prolene is known to cause less infection since it is a monofilament material. Staples: specialized staples used in surgery in place of sutures to close skin wounds. After completion of the procedure, deep tissues were closed with absorbable braided suture, then the skin will be closed by staples.
Sponsors
Indus Hospital and Health Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | Surgery till 1 year post-op | Wound healing will be assessed using Hollander Score |
| Complications | Surgery till 1 year post-op | — |
Countries
Pakistan
Outcome results
None listed