Trial Outcomes & Findings for Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™ (NCT NCT03462563)

Last Updated: 2022-08-10

Results Overview

Percentage of participants free of adhesions at the target incision site in each study group based on evaluation through laparoscopy at ileostomy reversal were reported.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

175 participants

Primary outcome timeframe

3 to 9 months after phase 1 operation

Results posted on

2022-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm: INTERCEED In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Overall Study STARTED	94	81
Overall Study COMPLETED	79	64
Overall Study NOT COMPLETED	15	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm: INTERCEED In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Overall Study Death	1	1
Overall Study Termination of study	2	1
Overall Study Adverse Event	1	3
Overall Study Unspecified reason	10	12
Overall Study Physician Decision	1	0

Baseline Characteristics

Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm: INTERCEED n=94 Participants In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=81 Participants Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).	Total n=175 Participants Total of all reporting groups
Age, Continuous	57.0 years STANDARD_DEVIATION 11.30 • n=5 Participants	59.7 years STANDARD_DEVIATION 9.34 • n=7 Participants	58.2 years STANDARD_DEVIATION 10.49 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	57 Participants n=7 Participants	129 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants	78 Participants n=7 Participants	171 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	94 Participants n=5 Participants	81 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 to 9 months after phase 1 operation

Population: The Intent-to-treat (ITT) set contained all randomized participants. Here "N" (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Percentage of participants free of adhesions at the target incision site in each study group based on evaluation through laparoscopy at ileostomy reversal were reported.

Outcome measures

Outcome measures
Measure	Treatment Arm: INTERCEED n=72 Participants In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=60 Participants Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Percentage of Participants Free of Adhesions at the Target Incision Site	86.1 percentage of participants	86.7 percentage of participants

SECONDARY outcome

Timeframe: 3 to 6 months after phase 1 operation

Population: The ITT set contained all randomized participants. Here "N" (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Number of participants with extent of adhesions at target incision site in Phase 2 operation were reported. The extent of adhesions (percentage of the area covered by adhesion) was evaluated based on Grade 1: mild, covering up to 25 percent (%) of the total area and length; Grade 2: moderate, covering 26%-50% of the total area and length; and Grade 3: severe, covering over 50% of the total area and length.

Outcome measures

Outcome measures
Measure	Treatment Arm: INTERCEED n=72 Participants In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=60 Participants Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Number of Participants With Extent of Adhesions at Target Incision Site in Phase 2 Operation No adhesion	62 Participants	52 Participants
Number of Participants With Extent of Adhesions at Target Incision Site in Phase 2 Operation Grade 1	5 Participants	3 Participants
Number of Participants With Extent of Adhesions at Target Incision Site in Phase 2 Operation Grade 2	3 Participants	1 Participants
Number of Participants With Extent of Adhesions at Target Incision Site in Phase 2 Operation Grade 3	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 to 9 months after phase 1 operation

Population: The ITT set contained all randomized participants. Here "N" (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Number of participants with severity of adhesions at target incision site in Phase 2 operation were reported. The severity of adhesions was evaluated based on Grade 1: filmy thickness, avascular; Grade 2: moderate thickness, limited vascularity and Grade 3: dense thickness, vascularized.

Outcome measures

Outcome measures
Measure	Treatment Arm: INTERCEED n=72 Participants In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=59 Participants Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Number of Participants With Severity of Adhesions at Target Incision Site in Phase 2 Operation No adhesion	62 Participants	52 Participants
Number of Participants With Severity of Adhesions at Target Incision Site in Phase 2 Operation Grade 1	7 Participants	2 Participants
Number of Participants With Severity of Adhesions at Target Incision Site in Phase 2 Operation Grade 2	3 Participants	5 Participants
Number of Participants With Severity of Adhesions at Target Incision Site in Phase 2 Operation Grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 to 9 months after phase 1 operation

Population: The ITT set contained all randomized participants. Here "N" (number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here "n" (number analyzed) signifies participants who were evaluated for a specified category.

Number of participants with extent of adhesions at four abdominal quadrants in Phase 2 operation were reported. The abdominal cavity was divided into four abdominal quadrants as: Right upper abdominal quadrant, Left upper abdominal quadrant, Right lower abdominal quadrant and Left lower abdominal quadrant and the extent of adhesions (percentage of the area covered by adhesion) was evaluated based on Grade 1: mild, covering up to 25% of the total area and length; Grade 2: moderate, covering 26%-50% of the total area and length; and Grade 3: severe, covering over 50% of the total area and length. One participant may have multiple sites of adhesion.

Outcome measures

Outcome measures
Measure	Treatment Arm: INTERCEED n=25 Participants In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=29 Participants Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Upper Abdominal Quadrant: Grade 1	7 Participants	9 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Upper Abdominal Quadrant: Grade 2	1 Participants	0 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Upper Abdominal Quadrant: Grade 3	0 Participants	0 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Upper Abdominal Quadrant: Grade 1	3 Participants	6 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Upper Abdominal Quadrant: Grade 2	1 Participants	0 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Upper Abdominal Quadrant: Grade 3	0 Participants	0 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Lower Abdominal Quadrant: Grade 1	11 Participants	12 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Lower Abdominal Quadrant: Grade 2	1 Participants	1 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Lower Abdominal Quadrant: Grade 3	0 Participants	0 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Lower Abdominal Quadrant: Grade 1	10 Participants	10 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Lower Abdominal Quadrant: Grade 2	0 Participants	0 Participants
Number of Participants With Extent of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Lower Abdominal Quadrant: Grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 to 6 months after phase 1 operation

Number of participants with severity of adhesions at four abdominal quadrants in Phase 2 operation were reported. The abdominal cavity was divided into four abdominal quadrants as: Right upper abdominal quadrant, Left upper abdominal quadrant, Right lower abdominal quadrant and Left lower abdominal quadrant and the severity of adhesions was evaluated based on Grade 1: filmy thickness, avascular; Grade 2: moderate thickness, limited vascularity and Grade 3: dense thickness, vascularized. One participant may have multiple sites of adhesion.

Outcome measures

Outcome measures
Measure	Treatment Arm: INTERCEED n=25 Participants In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=29 Participants Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Upper Abdominal Quadrant: Grade 1	7 Participants	8 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Upper Abdominal Quadrant: Grade 2	1 Participants	1 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Upper Abdominal Quadrant: Grade 3	0 Participants	0 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Upper Abdominal Quadrant: Grade 1	3 Participants	6 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Upper Abdominal Quadrant: Grade 2	1 Participants	0 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Upper Abdominal Quadrant: Grade 3	0 Participants	0 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Lower Abdominal Quadrant: Grade 1	11 Participants	10 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Lower Abdominal Quadrant: Grade 2	1 Participants	3 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Right Lower Abdominal Quadrant: Grade 3	0 Participants	0 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Lower Abdominal Quadrant: Grade 1	10 Participants	10 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Lower Abdominal Quadrant: Grade 2	0 Participants	0 Participants
Number of Participants With Severity of Adhesions at Four Abdominal Quadrants in Phase 2 Operation Left Lower Abdominal Quadrant: Grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 9 months after phase 1 operation

Population: The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol. Here "n" (number analyzed) is defined as the number of participants evaluable for a specified category.

Number of participants with mechanical ileus were reported. Incidence of mechanical ileus was defined as the mechanical ileus judged by investigators, which occurred 1 week after Phase 1 operation. Incidence of mechanical ileus was reported based on three categories: Post-Phase 1 operation through 7 days after Phase 1 operation (less than or equal to \[\<=\] 7 days) (for participants underwent Phase 1 operation), 7 days after Phase 1 operation through pre-Phase 2 operation (for participants underwent Phase 1 operation) and Post-Phase 2 operation (for participants underwent Phase 2 operation).

Outcome measures

Outcome measures
Measure	Treatment Arm: INTERCEED n=93 Participants In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=81 Participants Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Number of Participants With Mechanical Ileus Post-Phase 2 Operation (for Participants Underwent Phase 2 Operation)	1 Participants	0 Participants
Number of Participants With Mechanical Ileus Post-Phase 1 Operation Through 7 Days After Phase 1 Operation (<=7 days)	3 Participants	1 Participants
Number of Participants With Mechanical Ileus 7 Days After Phase 1 Operation Through pre-Phase 2 Operation	1 Participants	0 Participants

Adverse Events

Treatment Arm: INTERCEED

Serious events: 21 serious events

Other events: 61 other events

Deaths: 1 deaths

Control Arm: Standard of Care (SOC)

Serious events: 26 serious events

Other events: 44 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Richard Kocharian

Ethicon SARL

Phone: +1 609 6423787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Treatment Arm: INTERCEED n=93 participants at risk In participants assigned to the treatment arm, the INTERCEED was applied beneath the target incision site (the midline incision for the removal specimen) (Phase 1 operation). After 3-9 months of Phase 1 operation, participants undergo ileostomy reversal (Phase 2 operation).	Control Arm: Standard of Care (SOC) n=81 participants at risk Participants received standard of care treatment: no adhesion barrier, no placebo (Phase 1 operation).
Injury, poisoning and procedural complications Anastomotic leak	2.2% 2/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	2.5% 2/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Anastomotic haemorrhage	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Anastomotic stenosis	2.2% 2/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Postoperative ileus	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Gastrointestinal anastomotic stenosis	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Stoma site oedema	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Stoma site dermatitis	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Injury, poisoning and procedural complications Stoma obstruction	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Intestinal obstruction	4.3% 4/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	3.7% 3/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Subileus	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Large intestine polyp	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Mechanical ileus	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Intestinal perforation	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Gastritis	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Gastrointestinal disorders Abdominal pain	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Infections and infestations Pelvic infection	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	2.5% 2/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Infections and infestations Postoperative wound infection	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Infections and infestations Toxic shock syndrome	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Infections and infestations Systemic infection	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Infections and infestations Septic shock	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Infections and infestations Abdominal infection	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Infections and infestations Stoma site infection	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	3.7% 3/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to rectum	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer recurrent	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
General disorders Pyrexia	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
General disorders Death	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
General disorders Pelvic mass	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Cardiac disorders Acute myocardial infarction	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Cardiac disorders Atrial fibrillation	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Renal and urinary disorders Renal failure	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Renal and urinary disorders Ureterolithiasis	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Vascular disorders Aortic disorder	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Vascular disorders Venous thrombosis limb	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Immune system disorders Decreased immune responsiveness	1.1% 1/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	0.00% 0/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/93 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.	1.2% 1/81 • Up to 9.5 months The Safety Set (SS) contained all participants who were treated with study product or control (no adhesion barrier) as per the protocol.