Trial Outcomes & Findings for A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement (NCT NCT00940446)

Results Overview

Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Discharge from initial hospital stay (2-5 days post-op)

Results posted on

2018-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Insorb Staples Subcuticular Absorbable staples Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples.	Control Metal staple wound closure Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insorb Staples n=30 Participants Subcuticular Absorbable staples	Control n=30 Participants Metal staple wound closure	Total n=60 Participants Total of all reporting groups
Age, Continuous	62.3 years n=5 Participants	61.9 years n=7 Participants	61.9 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Number of staples placed	465 staples n=5 Participants	597 staples n=7 Participants	1062 staples n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insorb Staples n=30 Participants Subcuticular Absorbable staples Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples.	Control-metal Staples n=30 Participants Metal staple wound closure Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure.
Participants With Incisional Drainage, Swelling or Gaps of Incision	10 participants	16 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insorb Staples n=30 Participants Subcuticular Absorbable staples Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples.	Control-metal Staples n=30 Participants Metal staple wound closure Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure.
Participants With Wound Complications - Hematoma	0 participants	1 participants

Adverse Events

Insorb Staples

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr David A Fisher

OrthoIndy

Phone: (317) 802-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place