Trial Outcomes & Findings for Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination (NCT NCT00467857)

NCT ID: NCT00467857

Last Updated: 2012-09-18

Results Overview

Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 293 participants
• Primary outcome timeframe: Before surgery (prior to skin preparation) and after surgery (after closing fascia)
• Results posted on: 2012-09-18

Participant Flow

Patients were enrolled between April 2006 and February 2009 at 5 centers in the United States, Europe, Asia, and Latin America.

Of 300 patients assessed for eligibility, 7 were not allocated to treatment due to inclusion or exclusion criteria.

Participant milestones

Measure	InteguSeal* and Standard Surgical Preparation Solutions Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Overall Study STARTED	146	147
Overall Study COMPLETED	143	139
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Measure	InteguSeal* and Standard Surgical Preparation Solutions Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Overall Study Adverse Event	1	0
Overall Study Withdrew consent	2	0
Overall Study Death	0	1
Overall Study Discharged from court service	0	1
Overall Study Emergency care required	0	1
Overall Study Did not meet inclusion/exclusion criteri	0	2
Overall Study Discontinuation reason missing	0	3

Baseline Characteristics

Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination

Baseline characteristics by cohort

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=146 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=147 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.	Total n=293 Participants Total of all reporting groups
Age Continuous	63.18 years STANDARD_DEVIATION 8.53 • n=5 Participants	62.94 years STANDARD_DEVIATION 9.97 • n=7 Participants	63.06 years STANDARD_DEVIATION 9.28 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	18 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	129 Participants n=7 Participants	249 Participants n=5 Participants
Height	1.67 meters STANDARD_DEVIATION 0.10 • n=5 Participants	1.66 meters STANDARD_DEVIATION 0.09 • n=7 Participants	1.67 meters STANDARD_DEVIATION 0.10 • n=5 Participants
Weight	76.2 kilograms STANDARD_DEVIATION 14.4 • n=5 Participants	73.8 kilograms STANDARD_DEVIATION 12.0 • n=7 Participants	75.0 kilograms STANDARD_DEVIATION 13.3 • n=5 Participants
Body Mass Index (BMI)	27.3 kg/m^2 STANDARD_DEVIATION 4.0 • n=5 Participants	26.6 kg/m^2 STANDARD_DEVIATION 3.4 • n=7 Participants	26.9 kg/m^2 STANDARD_DEVIATION 3.71 • n=5 Participants
Obesity Obese (BMI>30.0 kg/m^2)	40 participants n=5 Participants	20 participants n=7 Participants	60 participants n=5 Participants
Obesity Not obese	106 participants n=5 Participants	127 participants n=7 Participants	233 participants n=5 Participants
Diabetes mellitus, type 1 or 2 present	49 participants n=5 Participants	49 participants n=7 Participants	98 participants n=5 Participants
Diabetes mellitus, type 1 or 2 absent	97 participants n=5 Participants	98 participants n=7 Participants	195 participants n=5 Participants
Tobacco Use yes	84 participants n=5 Participants	91 participants n=7 Participants	175 participants n=5 Participants
Tobacco Use no	62 participants n=5 Participants	56 participants n=7 Participants	118 participants n=5 Participants
Alcohol Use Yes	42 participants n=5 Participants	52 participants n=7 Participants	94 participants n=5 Participants
Alcohol Use No	104 participants n=5 Participants	95 participants n=7 Participants	199 participants n=5 Participants
New York Heart Association (NYHA) Functional Classification Class I	29 participants n=5 Participants	38 participants n=7 Participants	67 participants n=5 Participants
New York Heart Association (NYHA) Functional Classification Class II	73 participants n=5 Participants	61 participants n=7 Participants	134 participants n=5 Participants
New York Heart Association (NYHA) Functional Classification Class III	39 participants n=5 Participants	43 participants n=7 Participants	82 participants n=5 Participants
New York Heart Association (NYHA) Functional Classification Class IV	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Before surgery (prior to skin preparation) and after surgery (after closing fascia)

Population: Per protocol

Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=116 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=127 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site	-1.34 isolates Standard Deviation 1.0	-1.31 isolates Standard Deviation 1.0

PRIMARY outcome

Timeframe: Before surgery (prior to skin preparation) and after surgery (after closing fascia)

Population: Per protocol

Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=118 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=126 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site	-1.88 isolates Standard Deviation 1.1	-1.75 isolates Standard Deviation 1.0

SECONDARY outcome

Timeframe: Before surgery (prior to skin preparation) and after surgery (after closing fascia)

Population: Per protocol

Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=120 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=131 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site	-2.14 log CFU/mL Standard Deviation 1.4	-1.99 log CFU/mL Standard Deviation 1.3

SECONDARY outcome

Timeframe: Before surgery (prior to skin preparation) and after surgery (after closing fascia)

Population: Per protocol

Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=119 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=126 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site	-2.42 log CFU/mL Standard Deviation 1.3	-2.31 log CFU/mL Standard Deviation 1.2

SECONDARY outcome

Timeframe: Post-surgery

Population: Per protocol

Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=120 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=132 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Post-CABG Procedure Bacterial Count - Sternal Site	0.58 log CFU/mL Standard Deviation 1.0	0.83 log CFU/mL Standard Deviation 1.1

SECONDARY outcome

Timeframe: Post-surgery

Population: Per protocol

Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=119 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=127 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Post-CABG Procedure Bacterial Count - Graft Site	0.19 log CFU/mL Standard Deviation 0.5	0.34 log CFU/mL Standard Deviation 0.7

SECONDARY outcome

Timeframe: Before surgery (prior to skin preparation) and immediately after incision

Population: Per protocol

Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=116 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=127 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site	-1.53 isolates Standard Deviation 0.9	-1.59 isolates Standard Deviation 1.0

SECONDARY outcome

Timeframe: Before surgery (prior to skin preparation) and immediately after incision

Population: Per protocol

Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=118 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=126 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site	-1.95 isolates Standard Deviation 1.1	-1.98 isolates Standard Deviation 1.0

SECONDARY outcome

Timeframe: Before surgery (prior to skin preparation) and immediately after incision

Population: Per protocol

Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=120 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=131 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site	-2.51 log CFU/mL Standard Deviation 1.3	-2.54 log CFU/mL Standard Deviation 1.2

SECONDARY outcome

Timeframe: Before surgery (prior to skin preparation) and immediately after incision

Population: Per protocol

Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=119 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=126 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site	-2.51 log CFU/mL Standard Deviation 1.3	-2.58 log CFU/mL Standard Deviation 1.2

SECONDARY outcome

Timeframe: Immediately after surgical incision

Population: Per protocol

Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=120 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=132 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Post-incision Bacterial Count - Sternal Site	0.21 log CFU/mL Standard Deviation 0.7	0.26 log CFU/mL Standard Deviation 0.7

SECONDARY outcome

Timeframe: Immediately after surgical incision

Population: Per protocol

Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=119 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=127 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Post-incision Bacterial Count - Graft Site	0.10 log CFU/mL Standard Deviation 0.4	0.08 log CFU/mL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 30 days

Population: Intention to treat

Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=146 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=147 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Number of Patients With SSI at the Sternal Site and/or Graft Site	9 Participants	14 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Subset of Intention to treat participants with alcohol use, tobacco use, or obesity

Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site

Outcome measures

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=108 Participants Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=112 Participants Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)	5 Participants	11 Participants

Adverse Events

InteguSeal* and Standard Surgical Preparation Solutions

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard Surgical Preparation Solutions

Serious events: 8 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=146 participants at risk Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=147 participants at risk Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
General disorders Death	0.00% 0/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	2.0% 3/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
General disorders Sudden death	0.68% 1/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.00% 0/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Incision site infection	2.1% 3/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	1.4% 2/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Mediastinitis	1.4% 2/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	1.4% 2/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Osteomyelitis	0.00% 0/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.68% 1/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Wound infection	0.68% 1/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.00% 0/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Surgical and medical procedures Hospitalisation	0.00% 0/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.68% 1/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.

Other adverse events

Measure	InteguSeal* and Standard Surgical Preparation Solutions n=146 participants at risk Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.	Standard Surgical Preparation Solutions n=147 participants at risk Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Infections and infestations Arteriovenous graft site infection	0.68% 1/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.00% 0/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Incision site infection	2.1% 3/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	5.4% 8/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Mediastinitis	0.68% 1/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.00% 0/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Osteomyelitis	0.68% 1/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.00% 0/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Postoperative wound infection	0.00% 0/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.68% 1/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Infections and infestations Skin graft infection	0.00% 0/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.68% 1/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Skin and subcutaneous tissue disorders Erythema	0.68% 1/146 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.	0.00% 0/147 • 30 days Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.

Additional Information

Dr. Shu-Ping Yang

Kimberly-Clark Health Care

Phone: 770-587-7267

Email: Shu-Ping.Yang@kcc.com

Results disclosure agreements

• Principal investigator is a sponsor employee All publications and presentations resulting from this multi-center trial sponsored by Kimberly-Clark must be approved by all investigators and the sponsor.
• Publication restrictions are in place

Restriction type: OTHER