A Study to assess the safety and efficacy of instillation of bone marrow derived cells into perineal wounds of patients undergoing surgery for rectal cancer after Chemoradiotherapy with regard to improvement in wound healing.
Phase 1
- Registration Number
- CTRI/2010/091/000094
- Lead Sponsor
- CMCH, Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Patients diagnosed with carcinoma rectum undergoing Abdominoperineal excision following Long Course Chemoradiotherapy in Surgery Unit 5, using Conventional RT at 50.4 Gy over 28 fractions.
Exclusion Criteria
1.Gross contamination intra op from Rectum or Urethra
2.Known immunosuppression
3. Patients who were diagnosed with hematological disease.
4. Patients receiving conformal radiotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of safety and feasibility of interventionsTimepoint: As assessed intra-op, immediately post-op, in the ward (recovery) and at the first outpatient visit.
- Secondary Outcome Measures
Name Time Method 1.Perineal wound breakdown - incidence in this group as compared to historical controls.<br>2.Factors affecting wound healing <br>Timepoint: As assessed in the ward(recovery) and at the first out patient visit.