Clinical trial · Interventional
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study
Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| in Situ Breast Cancer | Breast Carcinoma In Situ | PROBABILISTIC | 0.70 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptive skin sutures. | Procedure | — | UNRESOLVED |
| Insertion of suction drain(s) following mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Suction drain
- description
- Patients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy.
- interventionNames
- Procedure: Insertion of suction drain(s) following mastectomy
- type
- EXPERIMENTAL
- label
- Adaptive suture
- description
- Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.
- interventionNames
- Procedure: Adaptive skin sutures.
Primary outcomes (1)
- measure
- Total amount of sera withdrawn from the wound cavity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy Exclusion Criteria: * age above 75 years and bad general state * pregnancy * autoimmune disease * non-radical excision * mastitis carcinomatosis * lymphangitis carcinomatosis * wound infection necessitating treatment
References
Publications (0)
Data not yet available