Vaginal reconstruction using a personalized degradable layered graft made from the patient’s own tissue
| ISRCTN | ISRCTN12529893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12529893 |
| Sponsor | Copenhagen University Hospital |
| Funders | Danmarks Frie Forskningsfond (DFF1, Independent Research Fund Denmark), Novo Nordisk Foundation Professorship in Pediatric Surgery grant, Novo Nordisk Found Pioneer grant |
- Submission date
- 22/03/2026
- Registration date
- 24/03/2026
- Last edited
- 23/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study aims to find out whether a new type of graft made from a patient’s own vaginal tissue can be used safely and effectively during vaginal reconstruction surgery. The graft is made in the operating theatre from a small sample of the patient’s tissue and placed into the surgical area to help healthy tissue grow during healing.
Who can participate?
Women aged 15 years and older who need surgery for vaginal stenosis, vaginal atresia or a horizontal vaginal septum may be able to take part. Women who have had similar surgery in the past using tissue taken from another part of the body may also be invited to join the control group. People cannot take part if they are receiving chemotherapy or certain immune treatments, have a known allergy to bovine products, have had radiation to the pelvis, or have specific immune conditions that affect the vagina.
What does the study involve?
Participants who need surgery will receive the new graft during their operation. A small tissue sample will be taken, prepared on a biodegradable mesh, and placed into the surgical area. After surgery, participants will be monitored for any problems and will attend check ups at about 6 months, 1 year and 2 years. These visits will include examinations, tissue samples from the graft area, and questionnaires about symptoms, sexual health and quality of life.
Participants in the control group will not receive surgery as part of this study. They will complete a set of questionnaires once. Their results will be compared with the results of the group receiving the new graft.
What are the possible benefits and risks of participating?
There may be no direct benefit. However, the new graft may help healthy vaginal tissue grow after surgery, which could improve healing and reduce complications. Risks include the usual risks linked to surgery, such as infection, bleeding or pain, as well as a small chance of allergic reactions. Participants will be monitored closely to manage any problems that arise.
Where is the study run from?
The study is run from Copenhagen University Hospital, Rigshospitalet, in Denmark.
When is the study starting and how long is it expected to run for?
The first participants are expected to join the study from 01 April 2026. The study is expected to continue until 2033.
Who is funding the study?
The study is funded by the Independent Research Fund Denmark and two grants from the Novo Nordisk Foundation.
Who is the main contact?
Professor Magdalena Fossum, mfos0019@regionh.dk
Contact information
Principal investigator, Scientific, Public
Lab. of Tissue Engineering
Dept. of Pediatric Surgery
Rigshospitalet
Blegdamsvej 9
Copenhagen
2100
Denmark
 ORCID ID |
0000-0002-6997-663X |
|---|---|
| Phone | +4521245658 |
| mfos0019@regionh.dk |
Public, Scientific
Lab. of Tissue Engineering
Blegdamsvej 9
Rigshospitalet
Copenhagen
2100
Denmark
| ORCID ID |
0009-0002-3985-8189 |
|---|---|
| Phone | +45 35453545 |
| anastasia.buch.kjeldgaard@regionh.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Historical |
| Assignment | Single |
| Purpose | Device feasibility, Treatment |
| Scientific title | Using the Personalized Layered Autologous Tissue Expansion graft in VAGinal reconstructive surgery and patient reported outcomes measures for comparison with previously treated patients |
| Study acronym | PLATE-VAG |
| Study objectives | The aim of the study is to evaluate the feasibility, safety, and clinical use of a new perioperative method for autologous tissue expansion in vaginal reconstructive surgery. |
| Ethics approval(s) |
Approved 14/10/2025, De Videnskabsetiske Komiteer for Region Hovedstaden - The Research Ethics Committee for the Capital Region (Borgervænget 3, ST, Copenhagen, 2100, Denmark; +45 3866 6395; vek@regionh.dk), ref: H-25043127 |
| Health condition(s) or problem(s) studied | Vaginal atresia, vaginal stenosis and vaginal septum needing surgical intervention. |
| Intervention | The participants in the study will consist of two groups 1. Patients diagnosed with a vaginal stenosis, vaginal atresia or vaginal horizontal septum with an indication for surgical correction (intervention group) Intervention: Surgical intervention will be performed withan autologous surgical graft called the Perioperative Layered Autologous Tissue Expansion (PLATE) graft. Briefly, the PLATE-graft consists of a minced biopsy of the patient’s own vaginal mucosa, spread on a biodegradable mesh and imbedded in a collagen hydrogel. The collagen hydrogel is compressed to expel its water content, and then sutured into the surgical vaginal wound to allow for tissue expansion during postoperative healing. The PLATE-graft is constructed perioperatively inside the operating theatre, next to the patient within 30 minutes. 2. Control patients who have previously undergone surgical correction for vaginal stenosis, vaginal atresia or vaginal horizontal septum using autologous donor tissue from another organ (e.g. buccal mucosa, intestine or skin) (control group). The intervention group and the control group will both answer questionnaires related to female health after at least 1 year after vaginal reconstructive surgery |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/01/2033 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target sample size at registration | 30 |
| Key inclusion criteria | Control group: 1. Can receive information in Danish or English and provide a signed informed consent 2. Previous surgical reconstruction of the vagina using implantation of non-vaginal tissue grafts or flaps due to stenosis, iatrogenic damage or congenital malformation Surgical group: 1. Can receive information in Danish or English and provide a signed informed consent 2. Indication for surgical reconstruction of vagina due to stenosis, iatrogenic damage or congenital malformation that would require implantation of non-vaginal tissue grafts or flaps to restore an epithelial lining |
| Key exclusion criteria | For both control and surgical groups: 1. Active chemotherapy or other immunomodulating treatment 2. Known allergy towards bovine proteins/products 3. Previous radiation therapy to the pelvic area or lower abdomen 4. Diagnosis of known immunological condition related to the vagina (e.g. lichen planus) |
| Date of first enrolment | 01/04/2026 |
| Date of final enrolment | 01/01/2031 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Blegdamsvej 9
Copenhagen
2100
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan |
Editorial Notes
23/03/2026: Trial's existence confirmed by Region Hovedstaden.
