## Protocol Section
### Identification Module
**NCT ID:** NCT06419855

**Brief Title:** Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair

**Official Title:** Post-approval, Multicenter Study to Evaluate the Efficacy and Safety of BIOSCAFF®H, a Human Collagen Graft, Compared to DuraGen®, a Bovine-derived Graft, in Patients Undergoing Dural Repair Following Cranial Surgery

#### Organization Study ID Info
**ID:** TOP-1122-IV
#### Organization
**Class:** INDUSTRY
**Full Name:** Top Health S.A.P.I DE C.V.
### Status Module
#### Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** CLINICAL RESEARCH PS MEXICO

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Top Health S.A.P.I DE C.V.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull; this material allows the regeneration of tissue that makes up one of the layers of the brain that was affected before or during surgery. The primary hypothesis of this study is that there will be no more than a 10% difference in outcomes between the BIOSCAFF®H device and the active comparator, DuraGen®, with respect to the incidence of cerebrospinal fluid leak or the presence of pseudomeningocele.

**Detailed Description:** This study will help describe the safety profile and other aspects such as quality of life of the subjects who received it. The primary objective of the study is to evaluate the efficacy of the BIOSCAFF® H graft in patients undergoing dural surgery in the absence of cerebrospinal fluid leakage compared to the active comparator.

This is a prospective, multicenter, cohort, post-approval study to evaluate the efficacy and safety of BIOSCAFF®H. It consists of a screening period and a follow-up period up to 52 weeks after surgery. Medical records of patients who underwent surgery less than 30 days post-operatively and were implanted with the BIOSCAFF®H human collagen dural substitute or the active bovine collagen-based comparator, DuraGen®, will be considered. It is estimated that approximately 86 dural surgery patients will be enrolled.

### Conditions Module

**Conditions:**

- Cerebrospinal Fluid Leakage

**Keywords:**

- Dural surgery

- Sealing

- Leakage

- Cerebrospinal fluid

- Collagen matrix graft

- Dura

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 86

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Is a porous cross-linked human collagen Matrix or Sponge, used as a scaffold in the repair and restoration of dura mater defects, following craniotomy, laminectomy or in general when there is intentional (surgical procedure) or accidental damage to the dura mater.

**Intervention Names:**

- Device: Human collagen matrix graft

**Label:** Human collagen matrix graft

#### Arm Group 2

**Description:** Is a porous type 1 collagen matrix derived from bovine Achilles tendon, this matrix is absorbed after 8 weeks and is used for the repair and restoration of dura mater defects.

**Intervention Names:**

- Device: Bovine collagen matrix graft

**Label:** Bovine collagen matrix graft

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Human collagen matrix graft

**Description:** Is a porous cross-linked human collagen Matrix or Sponge, used as a scaffold in the repair and restoration of dura mater defects, following craniotomy, laminectomy or in general when there is intentional (surgical procedure) or accidental damage to the dura mater.

**Name:** Human collagen matrix graft

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Bovine collagen matrix graft

**Description:** Is a porous type 1 collagen matrix derived from bovine Achilles tendon, this matrix is absorbed after 8 weeks and is used for the repair and restoration of dura mater defects.

**Name:** Bovine collagen matrix graft

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** The concentration of the immunoglobulins IgG, IgE, IgM, IgA in serum or plasma.

**Measure:** To evaluate the serum/plasma concentration of immunoglobulins IgG, IgE, IgM, IgA as possible indicators of immunogenicity in BIOSCAFF®H compared to those implanted with DuraGen®.

**Time Frame:** 180 days post-surgery

**Description:** Change in Manchester Scale Score (MSS) during the first 6 months after surgery. It evaluates and rates 7 scar parameters: scar color (perfect, slight, obvious, or gross mismatch to surrounding skin), skin texture (matte or shiny), relationship to surrounding skin (range from flush to keloid), texture (range from normal to hard), margins (distinct or indistinct), size (\<1 cm, 1-5 cm, \>5 cm), and single or multiple. Results are converted to a scale of 5 (excellent scar) to 28 (worst scar).

**Measure:** To evaluate wound healing 180 days after surgery

**Time Frame:** 180 days post-surgery

#### Primary Outcomes

**Description:** To evaluate effectiveness of BIOSCAFF®️H graph in patients who underwent dural surgery on the incidence of cerebrospinal fluid leakage versus an active comparator

**Measure:** Incidence of cerebrospinal fluid leakage

**Time Frame:** 52 weeks post-surgery

#### Secondary Outcomes

**Description:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ using the Modified Rankin Score (mRS-9Q), It consists of 9 questions to evaluate the degree of disability of the patient, with a minimum value of 0 indicating no symptoms and a maximum value of 5 indicating severe disability.

**Measure:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ at 60, 90 and 180 days post-surgery in patients who underwent dural surgery compared to day 30 post-surgery using the Modified Rankin Score (mRS-9Q).

**Time Frame:** 180 days post-surgery

**Description:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ using the Barthel Index, which consists of 10 questions to assess the patient's level of disability, with a minimum score of 0 and a maximum score of 100 indicating severe disability. The closer a subject's score is to 0, the more dependent he/she is; the closer to 100, the more independent he/she is.

**Measure:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ at 60, 90 and 180 days post-surgery in patients who underwent dural surgery compared to day 30 post-surgery using the Barthel Index.

**Time Frame:** 180 days post-surgery

**Description:** To compare the results of the SF-36 and EQ-5D-5L quality of life scales in dural surgery patients implanted with BIOSCAFF®H or DuraGen® on days 60, 90, and 180 postoperatively compared to day 30 postoperatively.

The SF-36 is a self-administered instrument consisting of 36 questions. For each scale, the responses to each question are coded and recoded (10 questions), and the results are converted to a scale from 0 (worst health) to 100 (best health).

The EQ-5D-5L scale is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic evaluation with five dimensions. The maximum value is 100, which represents the best health you can imagine, and the minimum value of 0 represents the worst health you can imagine. It should be used in conjunction with the EuroQol website.

After applying both scales to the patients, the results are compared.

**Measure:** Compare the quality of life in patients who underwent dural surgery and were implanted

**Time Frame:** 180 days post-surgery

**Description:** Frequency of surgical site infections at 30, 60, 90, and 180 days after surgery.

**Measure:** To evaluate the incidence of infection with BIOSCAFF®H at 30 days post-surgery compared to the active comparator and the safety of BIOSCAFF®H on the incidence of surgical site infections at 30, 60, 90 and 180 days post-surgery compared to DuraGen®.

**Time Frame:** 180 days post-surgery

**Description:** Adverse events and serious adverse events from day 0 through week 52 after surgery.

**Measure:** To evaluate the incidence of adverse events and serious adverse events for BIOSCAFF®H compared to DuraGen® from day 0 to week 52 after surgery.

**Time Frame:** 52 weeks post-surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults ≥18 years of age up to 70 years of age, of both sexes.
* Patients who agree to participate and are able to provide written informed consent.
* Patients who underwent dural surgery or duraplasty for pathological processes or who required dural grafting at the neurosurgeon's discretion with a maximum of 30 days postoperatively.
* Patients in need of an incision of at least 2 cm in length.

Exclusion Criteria:

* Presence of empyema/subdural abscess or any type of systemic infection affecting/infiltrating the dura mater detected by the physician prior to surgery.
* Diagnosis of malignant cranial tumor(NOTE: patients without a diagnosis of malignancy will still be allowed to enter the study).

  * The diagnosis of malignancy will be considered according to the classification of Tumors of the Central Nervous System, stipulated by the World Health Organization version 2021, considering the lowest taxonomic hierarchy (specific) of the tumor available in the diagnosis considering: Category, family or class, type and subtype.
  * The ICD-O morphological coding system will be used, to classify tumors as benign (Eligible) and malignant (Ineligible), considering: /0 for benign tumors; /1 nonspecific, borderline or of uncertain behavior as tumors that can be included in the study, while those coded as /2, /3 and /6 or metastatic tumors as ineligible. In APPENDIX 4 "Patient eligibility associated with the listing of tumors in the central nervous system" the classification of tumors according to the above-mentioned document is listed for clearer reference.
* Drowsy or comatose patients at the time of screening.
* Serum creatinine levels \>2.0 mg/dL.
* Patient with a total bilirubin level \>2.5 mg/dL.
* Previous surgery at the same site or patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery.
* Inability to read and understand protocol information by the participant.
* History of symptomatic hydrocephalus.
* Patients who have received chemotherapy or radiation therapy in the surgical region that was completed within 3 months prior to the planned surgery or are scheduled for the next 12 weeks.
* Known history of hemophilia or other clinically significant coagulopathy.
* Previous participation in any related device or investigational drug study within 30 days prior to screening.
* Medical history report of status epilepticus in the patient.
* Patients with uncontrolled diabetes according to ADA criteria: fasting glucose ≥200 mg/dL, HbA1C ≥8.5%.
* Patients in whom radiological contrast medium is contraindicated.
* Women who are breastfeeding or pregnant.
* Patients with a body mass index (BMI) ≥ 35 kg/m2.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients of private and public clinical care, who have undergone dural surgery, residents of different states of Mexico

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ana.villarruel@droxhealth.com

**Name:** Ana P. Villarruel Ornelas, BIB

**Phone:** +52 33 2316 2042

**Role:** CONTACT

**Contact 2:**

**Email:** yubitza.lara@droxhealth.com

**Name:** Yubitza I. Lara Vargas, BCSE

**Phone:** +52 33 2316 2042

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Top Health S.A.P.I DE C.V.

**Name:** Juan P. Aguilar Alemán, PhD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Top Health S.A.P.I DE C.V.

**Name:** Beni Camacho Perez, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Rosen CL, Steinberg GK, DeMonte F, Delashaw JB Jr, Lewis SB, Shaffrey ME, Aziz K, Hantel J, Marciano FF. Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects. Neurosurgery. 2011 Nov;69(5):1093-103; discussion 1103-4. doi: 10.1227/NEU.0b013e3182284aca.

**PMID:** 21670715

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M30548

- Name: Cerebrospinal Fluid Leak

- Relevance: HIGH

- As Found: Cerebrospinal Fluid Leakage

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: T1068

- Name: Cerebrospinal Fluid Leak

- Relevance: HIGH

- As Found: Cerebrospinal Fluid Leakage

### Condition Browse Module - Meshes

- ID: D000065634

- Term: Cerebrospinal Fluid Leak

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: LOW

- As Found: Unknown

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: LOW

- As Found: Unknown

- ID: M8108

- Name: Estradiol

- Relevance: LOW

- As Found: Unknown

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
