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Vaginal reconstruction using a personalized degradable layered graft made from the patient’s own tissue

Using the Personalized Layered Autologous Tissue Expansion graft in VAGinal reconstructive surgery and patient reported outcomes measures for comparison with previously treated patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12529893
Enrollment
30
Registered
2026-03-24
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal atresia, vaginal stenosis and vaginal septum needing surgical intervention. Urological and Genital Diseases

Interventions

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 (interve

Sponsors

Copenhagen University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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)

Countries

Denmark

Contacts

Public ContactMagdalena;Anastasia Fossum;Buch Kjeldgaard

;

mfos0019@regionh.dk;anastasia.buch.kjeldgaard@regionh.dk+4521245658;+45 35453545

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 15, 2026