Bruising, Drainage, Erythema, Pain
Conditions
Keywords
Insorb staples, Metal Staples
Brief summary
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.
Detailed description
Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.
Interventions
DEVICEInsorb staples
absorbable staples required for wound closure
DEVICEmetal staples (Ethicon metal stapler)
wound closure with metal staples
Sponsors
OrthoIndy
Orthopaedic Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient is 18 years or older * Patient or legal representative is able to understand and provide signed consent for the procedure * Patient is willing and able to return for required follow-up visits * Patient needs a total hip arthroplasty surgical procedure
Exclusion criteria
* Patient has an active infection * Patient is enrolled in another similar study * Patient has a known history of hepatitis * Patient has a known history of HIV * Patient has a known history of AIDs * Patient has a known history of IV drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Incisional Drainage, Swelling or Gaps of Incision | Discharge from initial hospital stay (2-5 days post-op) | Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Wound Complications - Hematoma | up to 6 weeks post-op | Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insorb Staples Subcuticular Absorbable staples | 30 |
| Control Metal staple wound closure | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Insorb Staples | Control | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years | 61.9 years | 61.9 years |
| Number of staples placed | 465 staples | 597 staples | 1062 staples |
| Sex: Female, Male Female | 15 Participants | 20 Participants | 35 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Participants With Incisional Drainage, Swelling or Gaps of Incision
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
Time frame: Discharge from initial hospital stay (2-5 days post-op)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insorb Staples | Participants With Incisional Drainage, Swelling or Gaps of Incision | 10 participants |
| Control-metal Staples | Participants With Incisional Drainage, Swelling or Gaps of Incision | 16 participants |
Secondary
Participants With Wound Complications - Hematoma
Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.
Time frame: up to 6 weeks post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insorb Staples | Participants With Wound Complications - Hematoma | 0 participants |
| Control-metal Staples | Participants With Wound Complications - Hematoma | 1 participants |