Using the Personalized Layered Autologous Tissue Expansion graft in VAGinal reconstructive surgery and patient reported outcomes measures for comparison with previously treated patients
Vaginal atresia, vaginal stenosis and vaginal septum needing surgical 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
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
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)