Burn's Associated Contracture Clinical Trial
Official title:
Phase 2 Of Injectable Collagenase (Xiaflex) For Burns' Associated Contracture
A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures
which result's from burn's healing process.
So far, treatment of choice in patients with burn's created movement limiting contractures,
concentrated around supportive care. Patients were referred to surgical intervention only if
necessary. Treatment by injecting an external enzyme is avant-garde and hasn't been done
under such conditions.
This study might introduce a new kind of treatment, which can be done in ambulatory
environment .This type of treatment might significantly improve patients' function and
quality of life, with no need for a surgical intervention.
Scientific Background:
Contracture is defined as a scar tissue that replaces the original tissue and leads to
shortening and tightening of the muscle results in a range of motion limitation and
deformity. Contracture creation is common in burn's healing process. The process itself
involves fibrosis of the effected area including intrusion towards the deep layers of the
skin, and can be described as ineffective healing process. In many cases these scars have
major functional and cosmetic implications that challenges the plastic surgery departments
around the world.
Creation of bands, webs and contractures close to a joint area can cause a significant
movement limitation and shortens the range of motion. Until recently, failure of treatment
with bandaging, splints and physiotherapy activity usually led to surgical intervention
involving many kinds of techniques ranging from simple incisions, Z-Plasties to skin grafts,
and flaps. All these methods were meant to release the contracture itself and restore the
functional capability.
A recent study showed that it's possible to use the collagenase enzyme in releasing
dupuytren's contracture by a simple injection, a procedure that can be preformed under
ambulatory conditions. This kind of contracture causes a fixed flexion of the fingers
towards the palm of the hand. The study was a double blinded, placebo controlled study and
involved 308 patients, all suffered from contracture with at least 20 degrees range of
movement limitation. In the end, it was proved beyond any doubt that collagenase is
effective in releasing and restoring range of motion of dupuytren's contracture. These
positive results might indicate the possibility of using collagenase in other kinds of
contractures.
In this study the investigators intend to perform a preliminary test of the effectiveness of
collagenase in treating contracture that developed due to the burn's healing process. As
comparison parameters the investigators will compare the range of motion before and after
treatment and subjective feeling of pain (again, before and after treatment) according to
VAS scale of pain. Also the investigators will try to monitor any kind of side effects that
might appear.
In the clinical aspect, this study might introduce the medical community with a new kind of
treatment protocols and even might decrease the need for surgical intervention in these
patients.
Goal:
A pilot experiment to test the efficiency of the enzyme Collagenase in treating contractures
which result's from burn's healing process.
Methods:
During the study the investigators will recruit about 10 patients which suffer from a known
contracture that causes movement's restriction and can be attributed to burn's healing
process. These patients will have to meet the exclusion and inclusion criteria of the study.
Patients will sign an informed consent in according to the Helsinki Committee, containing
the list of complications and side effects expected. Patients will go through Collagenase
enzyme injections according to the protocol that was conducted in the dupuytren's study.
Before performing the injections, the range of motion's limitations will be measured using
goniometer and a pain scale questionnaire (VAS) will be filled by the patient. Remeasuring
will be done in several time periods, after the first injection, ranging from 24 hours, a
week, 14 days and 28 days.
Expected results and research significance:
So far, treatment of choice in patients with burn's created movement limiting contractures,
concentrated around supportive care. Patients were referred to surgical intervention only if
necessary .Treatment by injecting an external enzyme is avant-garde and hasn't been done
under such conditions.
Injections attempts of various enzymes such as hyaluronidase , Collagenase and also
Gelatinase are documented in the literature as therapeutic trial for Keloid and hypertrophic
scars in the aesthetic aspect, were found ineffective. However, literature review found no
evidence of therapeutic attempts using Collagenase in burn's healing contracture for the
functional aspect. These processes are known to be fibrotic and rich with collagen
deposition.
This study might introduce a new kind of treatment, which can be done in ambulatory
environment .This type of treatment might significantly improve patients' function and
quality of life, with no need for a surgical intervention.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment