Trial Outcomes & Findings for A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision (NCT NCT03792737)

NCT ID: NCT03792737

Last Updated: 2022-04-05

Results Overview

Percentage of Participants with Grade A Healing of Surgical Incision

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 501 participants
• Primary outcome timeframe: 5-7days
• Results posted on: 2022-04-05

Participant Flow

one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so in protocol enrollment plan is 501 subjects, but actually received screen and randomization is 500 patients.

Participant milestones

Measure	Investigational Group 1 Spiral PDS Plus	Investigational Group 2 Spiral MONOCRYL Plus	Control groupEdit PDS Plus or Monocryl Plus
Overall Study STARTED	166	167	167
Overall Study Safety Analysis Set	162	161	162
Overall Study Full Analysis Set	162	160	162
Overall Study COMPLETED	160	159	158
Overall Study NOT COMPLETED	6	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision

Baseline characteristics by cohort

Measure	Investigational Group 1 n=162 Participants Spiral PDS Plus	Investigational Group 2 n=160 Participants Spiral MONOCRYL Plus	Control groupEdit n=162 Participants PDS Plus or Monocryl Plus	Total n=484 Participants Total of all reporting groups
Age, Continuous	40.1 years STANDARD_DEVIATION 10.66 • n=5 Participants	41.2 years STANDARD_DEVIATION 10.84 • n=7 Participants	40.3 years STANDARD_DEVIATION 11.32 • n=5 Participants	40.5 years STANDARD_DEVIATION 10.93 • n=4 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	118 Participants n=7 Participants	111 Participants n=5 Participants	336 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	42 Participants n=7 Participants	51 Participants n=5 Participants	148 Participants n=4 Participants
Race/Ethnicity, Customized Han	158 Participants n=5 Participants	157 Participants n=7 Participants	155 Participants n=5 Participants	470 Participants n=4 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants

PRIMARY outcome

Timeframe: 5-7days

Percentage of Participants with Grade A Healing of Surgical Incision

Outcome measures

Measure	Investigational group1 n=154 Participants Spiral PDS Plus	Investigational group2 n=157 Participants Spiral MONOCRYL Plus	Control Group n=156 Participants PDS Plus or Monocryl Plus
Wound Healing Grade	99.35 percentage Interval 96.44 to 99.98	98.73 percentage Interval 95.47 to 99.85	99.36 percentage Interval 96.48 to 99.98

SECONDARY outcome

Timeframe: during surgery, an average of around 12 Mins

the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)

Outcome measures

Measure	Investigational group1 n=162 Participants Spiral PDS Plus	Investigational group2 n=160 Participants Spiral MONOCRYL Plus	Control Group n=162 Participants PDS Plus or Monocryl Plus
Incision Closure Time	11.285 minutes Standard Deviation 3.2635	11.198 minutes Standard Deviation 3.1298	11.634 minutes Standard Deviation 3.4327

SECONDARY outcome

Timeframe: 5-7 Days after Surgery and 28-35 Days after Surgery

Population: Full Analysis Set

For the postoperative incisional pain score, a score of 0 means no pain, and a score of 10 means unbearable: severely affects sleep with other symptoms, or passive position.

Outcome measures

Measure	Investigational group1 n=162 Participants Spiral PDS Plus	Investigational group2 n=160 Participants Spiral MONOCRYL Plus	Control Group n=162 Participants PDS Plus or Monocryl Plus
Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) VAS Scale-Visit 4 (5-7 Days after Surgery)	1.5 Units Standard Deviation 1.49	1.5 Units Standard Deviation 1.61	1.4 Units Standard Deviation 1.39
Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) VAS Scale-Visit 5 (28-35 Days after Surgery)	0.45 Units Standard Deviation 0.775	0.63 Units Standard Deviation 0.991	0.66 Units Standard Deviation 1.319

SECONDARY outcome

Timeframe: 28-35 days

Total cosmetic score. Assessed by Central Imaging evaluators using incision pictures to evaluate healing status. range is from 0 to 5, 0 is best and 5 is worst

Outcome measures

Measure	Investigational group1 n=160 Participants Spiral PDS Plus	Investigational group2 n=159 Participants Spiral MONOCRYL Plus	Control Group n=162 Participants PDS Plus or Monocryl Plus
Modified Hollander Wound Evaluation Scale - FAS	0.2 scores on a scale Standard Deviation 0.53	0.1 scores on a scale Standard Deviation 0.38	0.1 scores on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: 5-7 days after surgery

Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1, 0 is better and 1 is worse

Outcome measures

Measure	Investigational group1 n=160 Participants Spiral PDS Plus	Investigational group2 n=160 Participants Spiral MONOCRYL Plus	Control Group n=160 Participants PDS Plus or Monocryl Plus
Health Related Quality of Life Scale (EQ-5D-5L)	0.8627 scores on a scale Standard Deviation 0.11007	0.8537 scores on a scale Standard Deviation 0.11843	0.8489 scores on a scale Standard Deviation 0.11648

SECONDARY outcome

Timeframe: 28-35 days after surgery

Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1. 0 is better and 1 is worse.

Outcome measures

Measure	Investigational group1 n=160 Participants Spiral PDS Plus	Investigational group2 n=159 Participants Spiral MONOCRYL Plus	Control Group n=158 Participants PDS Plus or Monocryl Plus
Health Related Quality of Life Scale (EQ-5D-5L)	0.9159 scores on a scale Standard Deviation 0.10566	0.9024 scores on a scale Standard Deviation 0.10738	0.9230 scores on a scale Standard Deviation 0.10489

SECONDARY outcome

Timeframe: 5-7 Days after surgery

Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100. 100 is best and 0 is worst.

Outcome measures

Measure	Investigational group1 n=160 Participants Spiral PDS Plus	Investigational group2 n=160 Participants Spiral MONOCRYL Plus	Control Group n=160 Participants PDS Plus or Monocryl Plus
Summary of EQ-5D VAS Score	88.1 scores on a scale Standard Deviation 10.02	87.7 scores on a scale Standard Deviation 10.32	88.3 scores on a scale Standard Deviation 9.45

SECONDARY outcome

Timeframe: 28-35 Days after surgery

Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100.

Outcome measures

Measure	Investigational group1 n=160 Participants Spiral PDS Plus	Investigational group2 n=159 Participants Spiral MONOCRYL Plus	Control Group n=158 Participants PDS Plus or Monocryl Plus
Summary of EQ-5D VAS Score	91.2 scores on a scale Standard Deviation 8.95	91.7 scores on a scale Standard Deviation 7.83	92.3 scores on a scale Standard Deviation 7.88

Adverse Events

Investigational Group 1

Serious events: 4 serious events

Other events: 44 other events

Deaths: 0 deaths

Investigational Group 2

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Control groupEdit

Serious events: 2 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	Investigational Group 1 n=162 participants at risk Spiral PDS Plus	Investigational Group 2 n=161 participants at risk Spiral MONOCRYL Plus	Control groupEdit n=162 participants at risk PDS Plus or Monocryl Plus
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.62% 1/162 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.62% 1/161 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast adenoma	0.62% 1/162 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/161 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.62% 1/162 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/161 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic lymphoma	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/161 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.62% 1/162 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.62% 1/161 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.62% 1/162 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Cardiac disorders Supraventricular tachycardia	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.62% 1/161 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Gastrointestinal disorders Asthenia	0.62% 1/162 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/161 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Skin and subcutaneous tissue disorders Skin oedema	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.62% 1/161 • Number of events 1 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	0.00% 0/162 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.

Other adverse events

Measure	Investigational Group 1 n=162 participants at risk Spiral PDS Plus	Investigational Group 2 n=161 participants at risk Spiral MONOCRYL Plus	Control groupEdit n=162 participants at risk PDS Plus or Monocryl Plus
Respiratory, thoracic and mediastinal disorders Productive cough	18.5% 30/162 • Number of events 30 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	19.9% 32/161 • Number of events 32 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	19.1% 31/162 • Number of events 31 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Metabolism and nutrition disorders Hypocalcaemia	3.7% 6/162 • Number of events 6 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	9.9% 16/161 • Number of events 16 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	9.9% 16/162 • Number of events 16 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 27/162 • Number of events 28 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	15.5% 25/161 • Number of events 26 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.	17.9% 29/162 • Number of events 29 • 35 days AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device. one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.

Additional Information

Xiaolei, Wang

Johnson & Johnson Medical Shanghai Ltd.

Phone: +86 21 33378749

Email: xwang183@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee The disclosure restriction on the principal investigator(PI) is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER