SurgiPerito Trial: High-Purity Type-I Collagen for Perito... | NCT07241091

NCT07241091

Status Module

Sponsor/Collaborators Module

Name	Class
JSS Medical College Hospital	UNKNOWN

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Purity Type-I Collagen-based Peritoneal Substitute	Active Comparator	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.	Device: High-Purity Type-I Collagen Scaffold
Standard Peritonectomy Closure	Active Comparator	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.	Procedure: Standard Peritonectomy Closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-Purity Type-I Collagen Scaffold	Device	Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Major Intra-abdominal Complications	Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery	2 months post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Individual Complication Rates	Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)	2 months
Time to Bowel Function Recovery	Time to bowel function recovery and diet tolerance

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
NAVEEN NARAYAN, MS, MCh	Adichunchanagiri Institute of Medical Sciences	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Adichunchanagiri Institute of Medical Sciences		Mandya	Karnataka	571448	India
JSS Medical College Hospital

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Naveen Narayan, KN rajeSh, ChethaN ShivaNNaiah, SuhaS N Gowda. Collagen-based Mesh in the Treatment of Posthernioplasty Mesh Infection in Ventral Hernias: A Case Series. Journal of Clinical and Diagnostic Research. 2024 Sep, Vol-18(9): PR01-PR03
39649230	Background	Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.
40747200

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 3, 2026

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

High Purity Type-I Collagen-based Peritoneal Substitute

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
BG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00130 BG00260

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0004 OG00111

Secondary

Individual Complication Rates

Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)

Posted

Count of Participants

Participants

2 months

ID	Title	Description
OG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
OG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Secondary

Time to Bowel Function Recovery

Time to bowel function recovery and diet tolerance

Posted

Median

Standard Deviation

days

1 month

ID	Title	Description
OG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
OG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Secondary

Length of Intensive Care Unit Stay

Duration of postoperative intensive care unit stay following cytoreductive surgery.

Posted

Mean

Standard Deviation

days

During index hospitalization

ID	Title	Description
OG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
OG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Secondary

Length of Hospital Stay

Total duration of hospitalization following cytoreductive surgery.

Posted

Mean

Standard Deviation

days

During index hospitalization

ID	Title	Description
OG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
OG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Secondary

Device-related Adverse Events

Any adverse event deemed related to the implanted High-Purity Type-I Collagen biomaterial, including mesh reaction, infection, seroma, rejection, or need for mesh removal, assessed within the 2-month postoperative period.

Patients undergoing cytoreductive surgery with peritonectomy did not have device, which is being evaluated in the study,

Posted

Count of Participants

Participants

Within 2 months after surgery

ID	Title	Description
OG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
OG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Secondary

MRI-Detected Intra-Abdominal Adhesions

Number of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging.

Posted

Count of Participants

Participants

Within 2 months after surgery

ID	Title	Description
OG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
OG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Secondary

Change in Quality of Life Domains (EORTC QLQ-C30)

Change from baseline in quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale.

For global health and functional scales, higher scores indicate better outcomes and higher change values represent improvement.

For pain (symptom scales), higher scores indicate worse symptoms; therefore, reductions from baseline represent improvement

Posted

Mean

Standard Deviation

score on a scale

Baseline to 2 months after surgery

ID	Title	Description
OG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.
OG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	High Purity Type-I Collagen-based Peritoneal Substitute	Patients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure. High-Purity Type-I Collagen Scaffold: Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.	0	30	0	30	2	30
EG001	Standard Peritonectomy Closure	Patients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care. Standard Peritonectomy Closure: Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.	0	30	6	30	16	30

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Reoperation for intra-abdominal complication	Surgical and medical procedures		Non-systematic Assessment		EG0000 events0 affected30 at risk EG0016 events6 affected30 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Adhesive small bowel obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected30 at risk EG0018 events8 affected30 at risk
Enterocutaneous fistula	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected30 at risk EG0013 events3 affected30 at risk
Surgical site infection	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected30 at risk EG0013 events3 affected30 at risk
Early incisional hernia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected30 at risk

First, although randomized and multicenter, the sample size was modest and powered primarily for short-term postoperative outcomes.

Second, the open-label design may introduce performance bias; however, objective endpoints and blinded outcome assessment were employed to mitigate this risk.

Third, while MRI provided valuable radiologic insight into adhesion formation, laparoscopy remains the gold standard for adhesion assessment and was not ethically justifiable in this context.

Certain Agreements

ID	Term
D010534	Peritoneal Neoplasms
D007415	Intestinal Obstruction
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D000008	Abdominal Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004067	Digestive System Neoplasms
D004066	Digestive System Diseases
D010532	Peritoneal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004701	Endocrine Gland Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

Units	Counts
Participants	OG00030 OG00130

Units	Counts
Participants	OG00030 OG00130