Infiltrations With Collagen in Episiotomy and Cesarean Scars

NCT04112888 | Completed

• 1 other identifier: CEI 17/73
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

One of the causes of pelvic pain is secondary to scarring due to episiotomy or cesarean after delivery.The pain of episiotomies or cesarean scars can be generalized at the level of the perineum, or more specifically at the level of the scar. For all these reasons, the presence of painful scars after a delivery, either by a cesarean or an episiotomy produces a perception of pelvic pain and change is your body schema and a series of negative connotations such as secondary dyspareunia, affective alterations, etc. To this, the investigators must add the important role that the psychological and social aspects can play in the development and perpetuation of a pain of these characteristics. The perception of pain is subjective and its intensity will be perceived based on many variables in each individual. The psycho-corporal representation of the episiotomy and/or cesarean section and its consequences will depend on each woman. In addition to the physical aspect, the scar of the episiotomy is the testimony of the birth and its complications. It causes a change in the representation of the body and the sex of the patient. The objective of this study is to evaluate the efficacy of collagen infiltrations in pelvic pain and the appearance of painful scars of episiotomies and/or cesareans compared to conventional treatment with rehabilitation.

Conditions

Pelvic Pain

Keywords

Episiotomy; Pain; Colagen

Outcome Measures

Primary Outcomes (2)

• Pain caused by the scar (VAS)

  Pain caused by the scar according to the Visual Analogue Scale (VAS). Range 0 to 10. Higher values represent worse pain.

  6 weeks after the end of treatment

• Pain caused by the scar (MPQ)

  Pain caused by the scar according to the Short Form McGill Pain (Questionnaire (MPQ). Range 0 to 78. Three dimensions: Sensory (12 ítems), Affective (3 ítems), Evaluative (1 ítem). Higher score higher level of pain.

  6 weeks after the end of treatment

Secondary Outcomes (4)

• Aspect of the scar (VSS)

  6 weeks after the end of treatment

• Aspect of the scar (PSAS)

  6 weeks after the end of treatment

• Subjective satisfaction of the clinician (PGI-I)

  6 weeks after the end of treatment

• Subjective satisfaction of the clinician (CGI-I)

  6 weeks after the end of treatment

Study Arms (2)

Collagen group

EXPERIMENTAL

Patients will receive 3 to 5 infiltrations of collagen on the scar once a week. Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes.

Combination Product: Collagen; Procedure: Rehabilitation sessions

Control group

ACTIVE COMPARATOR

Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes.

Procedure: Rehabilitation sessions

Interventions

Collagen COMBINATION_PRODUCT

Patients will receive 3 to 5 collagen infiltrations in the scar once per week. Patients with episiotomy will receive 3 collagen infiltrations while patients who underwent a cesarean section will receive 5 collagen infiltrations. The infiltration will be done by tunneling technique, that is, it will be applied along the scar, placing the needle almost tangential to the entire length of the area, then it will be injected and at the same time the needle will be removed. Infiltrations will be carried out intradermally, previously performing asepsis in the area to be infiltrated. 2 ml syringes will be used to infiltrate the episiotomy scars (we will use 1 vial of 2 ml ) and 5 ml for cesarean scars (2 vials of 2 ml ) and sterile needles of 30G, 13mm.

Collagen group

Rehabilitation sessions PROCEDURE

Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. There will be two sessions per week for four weeks. The sessions will last 45 minutes.

Collagen group; Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 18-45 years old.
• Between 2 and 36 months post-partum
• Accept participate in the study and sign the informed consent.

You may not qualify if:

• Mental or cognitive disorder that prevents comprehension.
• Being pregnant.
• Pacemaker carriers.
• On treatment with oral anticoagulants.
• Local infections at the point of infiltration.
• Total or partial denervation of the pelvic floor.
• Neurological diseases: AVC, LM, MS.

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (1)

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Location

MeSH Terms

Conditions

Pelvic Pain; Pain

Interventions

Collagen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Georgia Romero-Culleres, MD, PhD

  Althaia Xarxa Assistencial Universitària de Manresa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: October 2, 2019
• Study Start: May 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

ES (1)