Delayed Wound HealingNCT06698419
RADA16 on Mastoid Cavity Epithelialization
A study testing RADA16 gel application into mastoid cavity in people with Delayed Wound Healing, run by University of Florida.
Trial summary
The goal of this clinical trial is to see if the application of RADA16 gel can expedite and improve the healing process in participants after canal wall down mastoidectomy. The main questions are: Does application of RADA16 in the mastoid cavity after canal wall down mastoidectomy lead to faster healing (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Wound Healing
- What is being tested?
- RADA16 gel application into mastoid cavity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adults over the age of 18 years who require a canal wall down mastoidectomy for any reason including cholesteatoma, chronic suppurative middle ear disease, and neoplasm.
- Participants with history of canal wall up mastoidectomy who now require canal wall down mastoidectomy for any reason.
Who cannot join
- History of chronic immunodeficiency and autoimmune disease
- History of head and neck radiation
- Active tobacco use
- History of coronary artery disease
- History of peripheral vascular disease
- History of diabetes mellitus
- Known allergy to RADA16 gel or its components
- Vulnerable populations including children, neonates, pregnant women, prisoners, institutionalized individuals, and other individuals who are unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rex Haberman, MD contact
About this study
Official title: A Prospective Study: The Effect of RADA16 on Mastoid Cavity Epithelialization After Canal Wall Down Mastoidectomy
The goal of this clinical trial is to see if the application of RADA16 gel can expedite and improve the healing process in participants after canal wall down mastoidectomy. The main questions are:
- Does application of RADA16 in the mastoid cavity after canal wall down mastoidectomy lead to faster healing (i.e. epithelialization)?
- Is application of RADA16 in the mastoid cavity after canal wall down mastoidectomy associated with a decreased need for medications after surgery (i.e. antibiotics, steroids), less frequent in-office debridements, and less postoperative appointments?
Read more
Researchers will compare the healing outcomes in participants treated with RADA16 gel to those in a control group who do not receive the treatment.
Participants will:
- Undergo canal wall down mastoidectomy as recommended regardless of participation in the clinical trial
- Follow-up postoperatively for clinical assessment at 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, and 2 years. Participants may follow-up more frequently as needed.
Read the detailed description
Canal wall-down mastoidectomy is a commonly performed procedure for the treatment of cholesteatoma and chronic otitis media which involves elimination of the posterior wall of the external auditory canal and creation of a mastoid cavity. Unlike its canal wall-up counterpart, canal wall-down mastoidectomy allows for exteriorization and removal of cholesteatoma and middle ear disease in otherwise difficult-to-access middle ear subsites (e.g., sinus tympani and lateral epitympanum), and improved surveillance of these spaces post-operatively.
While there are many benefits to canal wall-down mastoidectomy in the right patient, the creation of a mastoid cavity is not without pitfalls. Normally, the tympanic cavity and mastoid air cells are covered in mucosal epithelium which is important in middle ear ventilation, protection from infection, and sound transmission to the inner ear. A mastoid cavity requires life-long maintenance and care and periodic visits to an otolaryngologist for debridement and surveillance. In creation of the mastoid cavity, the mucosa lining tympanic cavity and mastoid air cells is often removed along with cholesteatoma or other middle ear disease leaving exposed bone. Maturation of the mastoid cavity requires re-epithelization of the cavity which can take months to years to occur [2]. Inadequate or delayed epithelialization results in an "unstable" mastoid cavity which occurs in 20 to 60% of patients depending on the study [2-4]. Formation of granulation tissue and adhesions trap debris and lead to excessive crusting, chronic otorrhea, and intolerance to water exposure which further hinders mastoid cavity healing. In the researchers' experience, these patients often require more frequent office visits for debridement, application of ototopical agents, in-office cauterization, and revision mastoidectomy under general anesthesia in some cases.
Creation of a mastoid cavity requires making a wide enough cavity to allow for adequate ventilation, facilitate cavity inspection, and promote a self-cleaning environment. Other anatomic factors important for the surgeon include creating a mastoid cavity that is oval-shaped with a low facial ridge [5]. Because maturation of the mastoid cavity requires complete epithelization, a variety of methods have been explored to facilitate this process including application of a gelatin film [6], silastic sheeting [7], pedicled postauricular periosteal flap [8], and poly-N-acetyl-glucosamine sheet with fibrin glue [9]. At our institution and many others, mastoid cavities are packed with absorbable gelatin sponge (Gelfoam) which provides structural support for the newly formed mastoid cavity by securing soft tissue and grafts in place.
To date, there are no studies evaluating the use of RADA16 gel in human otologic surgery. RADA16 is a viscous solution of synthetic peptides that self-assemble into a transparent hydrogel matrix at physiological pH, mimicking the native extracellular matrix [10]. This unique property has enabled RADA16 to be adapted for various clinical applications. The biologic scaffold created by RADA16 acts as a physical barrier over wounds, inhibiting blood flow and promoting hemostasis. Its effectiveness has been demonstrated in various cardiovascular, gastrointestinal, and otolaryngologic procedures specifically endonasal [11-17].
The hydrogel matrix of RADA16 not only serves as a barrier but also acts as a biologic scaffold that supports wound healing, cell proliferation, and tissue regeneration [18]. Numerous in vivo studies have highlighted RADA16's potential as a wound healing agent. For example, it has shown promise in promoting mucosal regeneration after gastric ulcer formation [19], colon injury in a rat model [20], periodontal disease [21], and following endoscopic excision of gastrointestinal lesions [17]. Animal models have also demonstrated RADA16's ability to prevent scarring and adhesion formation, specifically in preventing esophageal stricture after submucosal resection [22]. In sinonasal surgery, RADA16 has proven beneficial in enhancing wound healing, preventing adhesion formation, and minimizing crusting [13, 23]. In a sheep model, RADA16 application to nasal mucosal defects led to reduced adhesion formation and accelerated healing [24]. More pertinent to this investigation, a study using a middle ear rodent model revealed that cultured middle ear epithelial cells treated with RADA16 were able to survive and repair mucosal defects, unlike those not treated with RADA16 [25].
Given the previous studies which include improved mucosal wound healing in the sinonasal cavity and a promising middle ear rodent study, researchers' aim to investigate and compare mastoid cavity epithelization rates after canal wall down mastoidectomy with and without the intraoperative application of RADA16 gel.
- Conditions
- Delayed Wound Healing
- Being tested
- RADA16 gel application into mastoid cavity
- Keywords
- Mastoidectomy, Healing, Biologic, Mastoid cavity, Mastoid cavity disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RADA16 gel application into mastoid cavityDevice
Also called PuraGel
A single application of RADA16 gel will be applied along the surface of the mastoid cavity intraoperatively prior to insertion of gelatin sponge packing. Application will involve a thin layer of gel just enough to cover the entire surface of the cavity.
| Study group | Role | What they receive |
|---|---|---|
| RADA16 Group | Experimental | Participants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Only participants in this arm will receive RADA16 gel into the mastoid cavity before placement of the gelatin sponge. Receives: Device: RADA16 gel application into mastoid cavity |
| Control Group | No intervention | Participants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Participants in this arm will not receive RADA16 gel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Mastoid Cavity Epithelialization at 1 Month
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Measured: Baseline and Postoperative Month 1
Time to Complete Mastoid Cavity Epithelialization at 2 Months
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Measured: Baseline and Postoperative Month 2
Time to Complete Mastoid Cavity Epithelialization at 3 Months
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Measured: Baseline and Postoperative Month 3
Time to Complete Mastoid Cavity Epithelialization at 6 Months
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Measured: Baseline and Postoperative Month 6
Time to Complete Mastoid Cavity Epithelialization at 1 Year
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Measured: Baseline and Postoperative Year 1
Time to Complete Mastoid Cavity Epithelialization at 18 Months
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Measured: Baseline and Postoperative Month 18
Time to Complete Mastoid Cavity Epithelialization at 2 Years
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Measured: Baseline and Postoperative Year 2
Secondary outcomes (3)
Total Number of Medications Prescribed Up To Complete Epithelialization
The total number of medications prescribed postoperatively to promote mastoid cavity healing will be assessed with focus on antibiotics and steroids.
Measured: Baseline to complete epithelialization, up to 2 years
Total Number of Mastoid Cavity Debridements Up to Complete Epithelialization
The total number of in-office mastoid cavity debridements will be recorded and assessed. Participants with faster and more robust healing are expected to require less in-office debridements.
Measured: Baseline to complete epithelialization, up to 2 years
Total Number of Postoperative Visits Up to Complete Epithelialization
The total number of postoperative visits (including set time points at 1 month, 2 months, 3 months, 9 months, 1 year, 18 months, and 2 years) will be recorded and assessed. Participants with faster and more robust healing are expected to not need additional visits, specifically for mastoid cavity healing related problems.
Measured: Baseline to complete epithelialization, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Delayed Wound HealingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to the experimental group or the control group. All participants will undergo a canal wall down mastoidectomy in standard fashion. Participants in the experimental group will receive RADA16 gel in the mastoid cavity at the conclusion of the surgery whereas participants in the control group will not.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- 3-D Matrix UK Ltd.
- Responsible party
- Sponsor
- Investigators
- Rex Haberman, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698419
- Sponsor's protocol ID
- IRB202401064
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no current plan to share IPD with other researchers.
Publications
Akiyama N, Yamamoto-Fukuda T, Takahashi H, Koji T. In situ tissue engineering with synthetic self-assembling peptide nanofiber scaffolds, PuraMatrix, for mucosal regeneration in the rat middle-ear. Int J Nanomedicine. 2013;8:2629-40. doi: 10.2147/IJN.S47279. Epub 2013 Jul 24.
PubMed 23926427Lee MF, Ananda A. Self-assembling RADA16 peptide hydrogel supports hemostasis, synechiae reduction, and wound healing in a sheep model of endoscopic nasal surgery. Auris Nasus Larynx. 2023 Jun;50(3):365-373. doi: 10.1016/j.anl.2022.09.012. Epub 2022 Oct 22.
PubMed 36283900Friedland Y, Bagot d'Arc MBD, Ha J, Delin C. The Use of Self-Assembling Peptides (PuraStat) in Functional Endoscopic Sinus Surgery for Haemostasis and Reducing Adhesion Formation. A Case Series of 94 Patients. Surg Technol Int. 2022 Nov 15;41:105-110. doi: 10.52198/22.STI.41.GS1694.
PubMed 35556241Oumrani S, Barret M, Bordacahar B, Beuvon F, Hochart G, Pagnon-Minot A, Coriat R, Batteux F, Prat F. Application of a self-assembling peptide matrix prevents esophageal stricture after circumferential endoscopic submucosal dissection in a pig model. PLoS One. 2019 Mar 12;14(3):e0212362. doi: 10.1371/journal.pone.0212362. eCollection 2019.
PubMed 30861007Takeuchi T, Bizenjima T, Ishii Y, Imamura K, Suzuki E, Seshima F, Saito A. Enhanced healing of surgical periodontal defects in rats following application of a self-assembling peptide nanofibre hydrogel. J Clin Periodontol. 2016 Mar;43(3):279-88. doi: 10.1111/jcpe.12515. Epub 2016 Mar 2.
PubMed 26788695Araki T, Mitsuyama K, Yamasaki H, Morita M, Tsuruta K, Mori A, Yoshimura T, Fukunaga S, Kuwaki K, Yoshioka S, Takedatsu H, Kakuma T, Akiba J, Torimura T. Therapeutic Potential of a Self-Assembling Peptide Hydrogel to Treat Colonic Injuries Associated with Inflammatory Bowel Disease. J Crohns Colitis. 2021 Sep 25;15(9):1517-1527. doi: 10.1093/ecco-jcc/jjab033.
PubMed 33596312Kakiuchi Y, Hirohashi N, Murakami-Murofushi K. The macroscopic structure of RADA16 peptide hydrogel stimulates monocyte/macrophage differentiation in HL60 cells via cholesterol synthesis. Biochem Biophys Res Commun. 2013 Apr 12;433(3):298-304. doi: 10.1016/j.bbrc.2013.02.105. Epub 2013 Mar 19.
PubMed 23518074Uraoka T, Ochiai Y, Fujimoto A, Goto O, Kawahara Y, Kobayashi N, Kanai T, Matsuda S, Kitagawa Y, Yahagi N. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointest Endosc. 2016 Jun;83(6):1259-64. doi: 10.1016/j.gie.2015.11.015. Epub 2015 Dec 1.
PubMed 26608126Subramaniam S, Kandiah K, Chedgy F, Fogg C, Thayalasekaran S, Alkandari A, Baker-Moffatt M, Dash J, Lyons-Amos M, Longcroft-Wheaton G, Brown J, Bhandari P. A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2021 Jan;53(1):27-35. doi: 10.1055/a-1198-0558. Epub 2020 Jul 17.
PubMed 32679602Stenson KM, Loftus IM, Chetter I, Fourneau I, Cavanagh S, Bicknell C, Loftus P. A Multi-Centre, Single-Arm Clinical Study to Confirm Safety and Performance of PuraStat(R), for the Management of Bleeding in Elective Carotid Artery Surgery. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221144307. doi: 10.1177/10760296221144307.
PubMed 36514251Pioche M, Camus M, Rivory J, Leblanc S, Lienhart I, Barret M, Chaussade S, Saurin JC, Prat F, Ponchon T. A self-assembling matrix-forming gel can be easily and safely applied to prevent delayed bleeding after endoscopic resections. Endosc Int Open. 2016 Apr;4(4):E415-9. doi: 10.1055/s-0042-102879. Epub 2016 Mar 30.
PubMed 27092320Morshuis, M., M. Schönbrodt, and J. Gummert, Safety and Performance of a Self-Assembling Peptide Haemostat for the Management of Bleeding after Left Ventricular Assist Device Implantation: Outcomes of a Post Market Clinical Follow-Up Study. Journal of Heart and Lung Transplantation, 2019. 38(4): p. S194-S194.
Lee MF, Ma Z, Ananda A. A novel haemostatic agent based on self-assembling peptides in the setting of nasal endoscopic surgery, a case series. Int J Surg Case Rep. 2017 Nov 20;41:461-464. doi: 10.1016/j.ijscr.2017.11.024. eCollection 2017.
PubMed 29546017Giritharan S, Salhiyyah K, Tsang GM, Ohri SK. Feasibility of a novel, synthetic, self-assembling peptide for suture-line haemostasis in cardiac surgery. J Cardiothorac Surg. 2018 Jun 15;13(1):68. doi: 10.1186/s13019-018-0745-2.
PubMed 29903028Branchi F, Klingenberg-Noftz R, Friedrich K, Burgel N, Daum S, Buchkremer J, Sonnenberg E, Schumann M, Treese C, Troger H, Lissner D, Epple HJ, Siegmund B, Stroux A, Adler A, Veltzke-Schlieker W, Autenrieth D, Leonhardt S, Fischer A, Jurgensen C, Pape UF, Wiedenmann B, Moschler O, Schreiner M, Strowski MZ, Hempel V, Huber Y, Neumann H, Bojarski C. PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study. Surg Endosc. 2022 May;36(5):2954-2961. doi: 10.1007/s00464-021-08589-6. Epub 2021 Jun 15.
PubMed 34129089
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study: The Effect of RADA16 on Mastoid Cavity Epithelialization After Canal Wall Down Mastoidectomy
- ClinicalTrials.gov ID
- NCT06698419
- Acronym / sponsor ID
- IRB202401064
- Conditions
- Delayed Wound Healing
- Keywords
- Mastoidectomy, Healing, Biologic, Mastoid cavity, Mastoid cavity disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- 3-D Matrix UK Ltd.
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to see if the application of RADA16 gel can expedite and improve the healing process in participants after canal wall down mastoidectomy. The main questions are:
- Does application of RADA16 in the mastoid cavity after canal wall down mastoidectomy lead to faster healing (i.e. epithelialization)?
- Is application of RADA16 in the mastoid cavity after canal wall down mastoidectomy associated with a decreased need for medications after surgery (i.e. antibiotics, steroids), less frequent in-office debridements, and less postoperative appointments?
Researchers will compare the healing outcomes in participants treated with RADA16 gel to those in a control group who do not receive the treatment.
Participants will:
- Undergo canal wall down mastoidectomy as recommended regardless of participation in the clinical trial
- Follow-up postoperatively for clinical assessment at 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, and 2 years. Participants may follow-up more frequently as needed.
Detailed description
Canal wall-down mastoidectomy is a commonly performed procedure for the treatment of cholesteatoma and chronic otitis media which involves elimination of the posterior wall of the external auditory canal and creation of a mastoid cavity. Unlike its canal wall-up counterpart, canal wall-down mastoidectomy allows for exteriorization and removal of cholesteatoma and middle ear disease in otherwise difficult-to-access middle ear subsites (e.g., sinus tympani and lateral epitympanum), and improved surveillance of these spaces post-operatively.
While there are many benefits to canal wall-down mastoidectomy in the right patient, the creation of a mastoid cavity is not without pitfalls. Normally, the tympanic cavity and mastoid air cells are covered in mucosal epithelium which is important in middle ear ventilation, protection from infection, and sound transmission to the inner ear. A mastoid cavity requires life-long maintenance and care and periodic visits to an otolaryngologist for debridement and surveillance. In creation of the mastoid cavity, the mucosa lining tympanic cavity and mastoid air cells is often removed along with cholesteatoma or other middle ear disease leaving exposed bone. Maturation of the mastoid cavity requires re-epithelization of the cavity which can take months to years to occur [2]. Inadequate or delayed epithelialization results in an "unstable" mastoid cavity which occurs in 20 to 60% of patients depending on the study [2-4]. Formation of granulation tissue and adhesions trap debris and lead to excessive crusting, chronic otorrhea, and intolerance to water exposure which further hinders mastoid cavity healing. In the researchers' experience, these patients often require more frequent office visits for debridement, application of ototopical agents, in-office cauterization, and revision mastoidectomy under general anesthesia in some cases.
Creation of a mastoid cavity requires making a wide enough cavity to allow for adequate ventilation, facilitate cavity inspection, and promote a self-cleaning environment. Other anatomic factors important for the surgeon include creating a mastoid cavity that is oval-shaped with a low facial ridge [5]. Because maturation of the mastoid cavity requires complete epithelization, a variety of methods have been explored to facilitate this process including application of a gelatin film [6], silastic sheeting [7], pedicled postauricular periosteal flap [8], and poly-N-acetyl-glucosamine sheet with fibrin glue [9]. At our institution and many others, mastoid cavities are packed with absorbable gelatin sponge (Gelfoam) which provides structural support for the newly formed mastoid cavity by securing soft tissue and grafts in place.
To date, there are no studies evaluating the use of RADA16 gel in human otologic surgery. RADA16 is a viscous solution of synthetic peptides that self-assemble into a transparent hydrogel matrix at physiological pH, mimicking the native extracellular matrix [10]. This unique property has enabled RADA16 to be adapted for various clinical applications. The biologic scaffold created by RADA16 acts as a physical barrier over wounds, inhibiting blood flow and promoting hemostasis. Its effectiveness has been demonstrated in various cardiovascular, gastrointestinal, and otolaryngologic procedures specifically endonasal [11-17].
The hydrogel matrix of RADA16 not only serves as a barrier but also acts as a biologic scaffold that supports wound healing, cell proliferation, and tissue regeneration [18]. Numerous in vivo studies have highlighted RADA16's potential as a wound healing agent. For example, it has shown promise in promoting mucosal regeneration after gastric ulcer formation [19], colon injury in a rat model [20], periodontal disease [21], and following endoscopic excision of gastrointestinal lesions [17]. Animal models have also demonstrated RADA16's ability to prevent scarring and adhesion formation, specifically in preventing esophageal stricture after submucosal resection [22]. In sinonasal surgery, RADA16 has proven beneficial in enhancing wound healing, preventing adhesion formation, and minimizing crusting [13, 23]. In a sheep model, RADA16 application to nasal mucosal defects led to reduced adhesion formation and accelerated healing [24]. More pertinent to this investigation, a study using a middle ear rodent model revealed that cultured middle ear epithelial cells treated with RADA16 were able to survive and repair mucosal defects, unlike those not treated with RADA16 [25].
Given the previous studies which include improved mucosal wound healing in the sinonasal cavity and a promising middle ear rodent study, researchers' aim to investigate and compare mastoid cavity epithelization rates after canal wall down mastoidectomy with and without the intraoperative application of RADA16 gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to the experimental group or the control group. All participants will undergo a canal wall down mastoidectomy in standard fashion. Participants in the experimental group will receive RADA16 gel in the mastoid cavity at the conclusion of the surgery whereas participants in the control group will not.
| Arm | Type | Receives |
|---|---|---|
| RADA16 Group | Experimental | Device: RADA16 gel application into mastoid cavityParticipants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Only participants in this arm will receive RADA16 gel into the mastoid cavity before placement of the gelatin sponge. |
| Control Group | No intervention | –Participants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Participants in this arm will not receive RADA16 gel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English-speaking adults over the age of 18 years who require a canal wall down mastoidectomy for any reason including cholesteatoma, chronic suppurative middle ear disease, and neoplasm.
- Participants with history of canal wall up mastoidectomy who now require canal wall down mastoidectomy for any reason.
Key exclusion criteria (8 listed)
- History of chronic immunodeficiency and autoimmune disease
- History of head and neck radiation
- Active tobacco use
- History of coronary artery disease
- History of peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RADA16 gel application into mastoid cavityAlso: PuraGelA single application of RADA16 gel will be applied along the surface of the mastoid cavity intraoperatively prior to insertion of gelatin sponge packing. Application will involve a thin layer of gel just enough to cover the entire surface of the cavity. | Device | RADA16 Group |
Primary outcome
Time to Complete Mastoid Cavity Epithelialization at 1 Month
Time frame: Baseline and Postoperative Month 1
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Time to Complete Mastoid Cavity Epithelialization at 2 Months
Time frame: Baseline and Postoperative Month 2
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Time to Complete Mastoid Cavity Epithelialization at 3 Months
Time frame: Baseline and Postoperative Month 3
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Time to Complete Mastoid Cavity Epithelialization at 6 Months
Time frame: Baseline and Postoperative Month 6
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Time to Complete Mastoid Cavity Epithelialization at 1 Year
Time frame: Baseline and Postoperative Year 1
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Time to Complete Mastoid Cavity Epithelialization at 18 Months
Time frame: Baseline and Postoperative Month 18
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
Time to Complete Mastoid Cavity Epithelialization at 2 Years
Time frame: Baseline and Postoperative Year 2
The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epithelialization.
3 secondary outcomes
Total Number of Medications Prescribed Up To Complete Epithelialization
Time frame: Baseline to complete epithelialization, up to 2 years
Total Number of Mastoid Cavity Debridements Up to Complete Epithelialization
Time frame: Baseline to complete epithelialization, up to 2 years
Total Number of Postoperative Visits Up to Complete Epithelialization
Time frame: Baseline to complete epithelialization, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 23926427Akiyama N, Yamamoto-Fukuda T, Takahashi H, Koji T. In situ tissue engineering with synthetic self-assembling peptide nanofiber scaffolds, PuraMatrix, for mucosal regeneration in the rat middle-ear. Int J Nanomedicine. 2013;8:2629-40. doi: 10.2147/IJN.S47279. Epub 2013 Jul 24.
- Background: PubMed 36283900Lee MF, Ananda A. Self-assembling RADA16 peptide hydrogel supports hemostasis, synechiae reduction, and wound healing in a sheep model of endoscopic nasal surgery. Auris Nasus Larynx. 2023 Jun;50(3):365-373. doi: 10.1016/j.anl.2022.09.012. Epub 2022 Oct 22.
- Background: PubMed 35556241Friedland Y, Bagot d'Arc MBD, Ha J, Delin C. The Use of Self-Assembling Peptides (PuraStat) in Functional Endoscopic Sinus Surgery for Haemostasis and Reducing Adhesion Formation. A Case Series of 94 Patients. Surg Technol Int. 2022 Nov 15;41:105-110. doi: 10.52198/22.STI.41.GS1694.
- Background: PubMed 30861007Oumrani S, Barret M, Bordacahar B, Beuvon F, Hochart G, Pagnon-Minot A, Coriat R, Batteux F, Prat F. Application of a self-assembling peptide matrix prevents esophageal stricture after circumferential endoscopic submucosal dissection in a pig model. PLoS One. 2019 Mar 12;14(3):e0212362. doi: 10.1371/journal.pone.0212362. eCollection 2019.
- Background: PubMed 26788695Takeuchi T, Bizenjima T, Ishii Y, Imamura K, Suzuki E, Seshima F, Saito A. Enhanced healing of surgical periodontal defects in rats following application of a self-assembling peptide nanofibre hydrogel. J Clin Periodontol. 2016 Mar;43(3):279-88. doi: 10.1111/jcpe.12515. Epub 2016 Mar 2.
- Background: PubMed 33596312Araki T, Mitsuyama K, Yamasaki H, Morita M, Tsuruta K, Mori A, Yoshimura T, Fukunaga S, Kuwaki K, Yoshioka S, Takedatsu H, Kakuma T, Akiba J, Torimura T. Therapeutic Potential of a Self-Assembling Peptide Hydrogel to Treat Colonic Injuries Associated with Inflammatory Bowel Disease. J Crohns Colitis. 2021 Sep 25;15(9):1517-1527. doi: 10.1093/ecco-jcc/jjab033.
- Background: PubMed 23518074Kakiuchi Y, Hirohashi N, Murakami-Murofushi K. The macroscopic structure of RADA16 peptide hydrogel stimulates monocyte/macrophage differentiation in HL60 cells via cholesterol synthesis. Biochem Biophys Res Commun. 2013 Apr 12;433(3):298-304. doi: 10.1016/j.bbrc.2013.02.105. Epub 2013 Mar 19.
- Background: PubMed 26608126Uraoka T, Ochiai Y, Fujimoto A, Goto O, Kawahara Y, Kobayashi N, Kanai T, Matsuda S, Kitagawa Y, Yahagi N. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointest Endosc. 2016 Jun;83(6):1259-64. doi: 10.1016/j.gie.2015.11.015. Epub 2015 Dec 1.
- Background: PubMed 32679602Subramaniam S, Kandiah K, Chedgy F, Fogg C, Thayalasekaran S, Alkandari A, Baker-Moffatt M, Dash J, Lyons-Amos M, Longcroft-Wheaton G, Brown J, Bhandari P. A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2021 Jan;53(1):27-35. doi: 10.1055/a-1198-0558. Epub 2020 Jul 17.
- Background: PubMed 36514251Stenson KM, Loftus IM, Chetter I, Fourneau I, Cavanagh S, Bicknell C, Loftus P. A Multi-Centre, Single-Arm Clinical Study to Confirm Safety and Performance of PuraStat(R), for the Management of Bleeding in Elective Carotid Artery Surgery. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221144307. doi: 10.1177/10760296221144307.
- Background: PubMed 27092320Pioche M, Camus M, Rivory J, Leblanc S, Lienhart I, Barret M, Chaussade S, Saurin JC, Prat F, Ponchon T. A self-assembling matrix-forming gel can be easily and safely applied to prevent delayed bleeding after endoscopic resections. Endosc Int Open. 2016 Apr;4(4):E415-9. doi: 10.1055/s-0042-102879. Epub 2016 Mar 30.
- BackgroundMorshuis, M., M. Schönbrodt, and J. Gummert, Safety and Performance of a Self-Assembling Peptide Haemostat for the Management of Bleeding after Left Ventricular Assist Device Implantation: Outcomes of a Post Market Clinical Follow-Up Study. Journal of Heart and Lung Transplantation, 2019. 38(4): p. S194-S194.
- Individual participant dataSharing planned: No. There is no current plan to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rex Haberman, MD contact
Rex Haberman, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing RADA16 gel application into mastoid cavity in people with Delayed Wound Healing, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Braeden Lovett, MD (240-672-8082, braedenlovett@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Mastoid Cavity Epithelialization at 1 Month (time frame: Baseline and Postoperative Month 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698419, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.