Trial Outcomes & Findings for An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery (NCT NCT01002287)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

10-12 Weeks post Initial Surgery for J-Pouch

Results posted on

2014-11-20

Participant Flow

Study Initiation: 31October2009 Study Termination: 24March2010 Study was conducted in hospitals.

Participant milestones

Participant milestones
Measure	SprayShield Adhesion Barrier SprayShield Adhesion Barrier + Good Surgical Technique	Control Good Surgical Technique Alone
Overall Study STARTED	8	3
Overall Study COMPLETED	8	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SprayShield Adhesion Barrier n=8 Participants SprayShield Adhesion Barrier + Good Surgical Technique	Control n=3 Participants Good Surgical Technique Alone	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	48.5 years STANDARD_DEVIATION 12.6 • n=5 Participants	37.7 years STANDARD_DEVIATION 19.8 • n=7 Participants	45.5 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Czech Republic	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Poland	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 10-12 Weeks post Initial Surgery for J-Pouch

Population: All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.

Outcome measures

Outcome measures
Measure	SprayShield Adhesion Barrier n=8 Participants SprayShield Adhesion Barrier	Control n=3 Participants Good Surgical Technique Alone
The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.	37.5 percentage of subjects with adhesions	66.7 percentage of subjects with adhesions

SECONDARY outcome

Timeframe: Average 10-12 weeks post surgery

Population: All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan.

Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are "1", "2", and "3". Subjects without adhesions were assigned a severity rating of "0".

Outcome measures

Outcome measures
Measure	SprayShield Adhesion Barrier n=8 Participants SprayShield Adhesion Barrier	Control n=3 Participants Good Surgical Technique Alone
Severity of Adhesions	0.9 units on a scale Standard Deviation 1.2	1.3 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: average 10-12 weeks post surgery

Population: These patients must have values for length of the incision associated with adhesions (cm) and for length of initial midline incision (cm) in order to calculate Extent of Adhesion Involvement (%). NOTE: Extent of Adhesion Involvement (%) = length of the incision associated with adhesions (cm) / length of initial midline incision (cm) \* 100.

The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.

Outcome measures

Outcome measures
Measure	SprayShield Adhesion Barrier n=1 Participants SprayShield Adhesion Barrier	Control n=2 Participants Good Surgical Technique Alone
Adhesion Involvement Along the Midline Incision (Percentage)	66.7 percentage of midline incision Standard Deviation 0	76.3 percentage of midline incision Standard Deviation 33.5

SECONDARY outcome

Timeframe: average 10-12 weeks post surgery

Population: All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan.

The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.

Outcome measures

Outcome measures
Measure	SprayShield Adhesion Barrier n=8 Participants SprayShield Adhesion Barrier	Control n=3 Participants Good Surgical Technique Alone
Mobilization Time	41.0 minutes Standard Deviation 13.7	43.3 minutes Standard Deviation 2.9

Adverse Events

SprayShield Adhesion Barrier

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SprayShield Adhesion Barrier n=8 participants at risk SprayShield Adhesion Barrier + Good Surgical Technique	Control n=3 participants at risk Good Surgical Technique Alone
Musculoskeletal and connective tissue disorders Fasciitis	12.5% 1/8 • Number of events 1	0.00% 0/3
Metabolism and nutrition disorders Dehydration	12.5% 1/8 • Number of events 2	0.00% 0/3
Injury, poisoning and procedural complications Surgical Skin Tear	0.00% 0/8	33.3% 1/3 • Number of events 1

Other adverse events

Other adverse events
Measure	SprayShield Adhesion Barrier n=8 participants at risk SprayShield Adhesion Barrier + Good Surgical Technique	Control n=3 participants at risk Good Surgical Technique Alone
Blood and lymphatic system disorders Leukocytosis	12.5% 1/8 • Number of events 1	0.00% 0/3
General disorders Impaired Healing	12.5% 1/8 • Number of events 1	0.00% 0/3
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1	0.00% 0/3
Investigations Hepatic enzyme increased	12.5% 1/8 • Number of events 1	0.00% 0/3

Additional Information

Stefani Battaglia

Integra LifeSciences

Phone: 44 7880 732691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place